(511 days)
K11016
No
The device description and performance studies focus on mechanical and material properties, fluid dynamics, and biocompatibility. There is no mention of AI or ML in the intended use, device description, or performance evaluation.
No
Explanation: The device is described as a flow control and conduit device for IV fluid delivery, allowing for various fluid management tasks. It does not exert any direct therapeutic action on the patient.
No
This device is a flow control and conduit device used for delivering IV fluids, drugs, and blood. It does not perform any diagnostic function.
No
The device description clearly details a physical manifold/stopcock with multiple ports, handles, connectors, and a manual operating mechanism. It is a hardware device for fluid delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "serving as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the physical components and function of a manifold/stopcock for managing fluid flow in an IV line. It describes connections, handles, and mechanisms for directing fluids. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed are related to the physical and chemical properties of the device, its ability to handle fluids and pressure, and its biocompatibility for use in the body. There are no studies related to the accuracy or performance of a diagnostic test.
- Predicate Devices: The predicate devices listed are also described as stopcocks and manifolds, which are devices used for fluid management in IV therapy, not for in vitro diagnostics.
In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device's function is entirely focused on the delivery and management of fluids directly into the patient's vascular system.
N/A
Intended Use / Indications for Use
SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.
Product codes
FMG
Device Description
Elcam modified SafePort™ Manifold (also identified as SafePort™ Manifold) is used in Operating Room (OR) and Intensive Care Unit (ICU) to assist the physician and mainly the anesthesiologist in delivering IV drugs and fluids during and after operation.
Elcam's SafePort™ Manifold is designated for single use only (disposable) and its recommended maximal use duration is up to 24 hours.
Liquid compatibility: Elcam's SafePort™ Manifold is compatible with common fluids used in I.V. therapy, anesthesia and monitoring, including blood transfusion. The SafePort™ Manifold is made of a body with 1-5 side ports and 1-5 handles (depends on the number of ports).
Each port has a male or female connector (luer). Male connectors also include a nut (rotator) for locking over the female luer of the connected component. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock/Manifold body.
Operating mechanism is manual and simple operated by twisting the handle position to determine fluid direction.
Between each handle and port housing an Elastomer may be placed to function as a pressure Luer Activated Valve (LAV) as an option to standard open female luer. The LAV is welded to the manifold body's fluid line at the female side port(s) in order to avoid back flow (reflux) and to serve as closed port. A rotator is assembled on the proximal male port (which is connected toward the patient) in order to enable connection locking. The distal female port is connected to the I.V Set to accept the delivered drug or fluid. Open ports (female and male) may be provided with or without covers.
Design wise, the modified SafePort™ Manifold relies on Elcam legally marketed SafePort™ Manifold cleared under K111016 that was modified as follow:
The SafePort™ Handle was modified for better producibility: Elastomeric material was changed, a cone-shape was added to the handle stem at the sealing area, as well as "door" shape fluid entrance added instead of around the entire stem. Cosmetic/visual non-functional changes were also implemented. The SafePort™ Body was changed to fit the handle changes: The stopper, dimensions luer compliance with ISO 80369-7, side port LAV female thread connection improvements and cosmetic/visual changes. Additional green colorant was added to the existing Caps' colorants.
Transfusion use was added to the SafePort™ indications for use statement to align Elcam SafePort™ with all other Stopcock and Manifold products (as in the primary predicate device cleared under K060231) that share the same indications for use, basic fluid path design and material types. Labeling materials were revised to include the additional transfusion claim.
All modifications were evaluated using well-established tests' methods previously utilized by Elcam or conducted per FDA recognized consensus standards and provided as summary tabulated in a risk analysis format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room (OR) and Intensive Care Unit (ICU), physician and anesthesiologist.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing was conducted to validate the changes presented in the 510(k) Submission. Tests were based on recognized consensus standards or Elcam's internal existing test methods.
The tests conducted were:
- Biocompatibility tests according to ISO 10993-1:2018 and additional parts, including Cytotoxicity, Maximization Sensitization, Intracutaneous Study, Acute Systemic Toxicity, Pyrogen Study - Material-Mediated, Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), and Platelet Activation. All tests performed on final-sterile devices.
- Initial handle torque test based on Elcam internal protocol (K032393).
- Handle stopper torque (override) test based on Elcam internal protocol (K111016).
- Leakage tests using pressures of 200 kPa (2 bar) and 300 kPa (3 bar) according to ISO 8536-10:2015.
- Leakage test using pressure of 50 kPa (0.5 bar) according to ISO 8536-10:2015.
- Vacuum test according to ISO 8536-4:2010.
- Handle "door" burst pressure test based on Elcam internal protocol (K111016).
- Chemical resistance test (Lipid resistance) for 24 hours based on Elcam internal protocol (K111016).
- Flow rate test according to ISO 8536-4:2010.
- Particulate contamination test according to ISO 8536-4:2010.
- Subvisible Particulate Matter test according to USP .
- Luer tests according to ISO 80369-7:2016 and ISO 80369-20:2015, including Positive pressure liquid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, and Resistance to overriding.
- Luer dimensions measurement based on Elcam internal protocol.
- LAV cap wiping effectiveness according to AAMI TIR30:2011/(R)2016, ISO 11737-1:2018, and FDA's Guidance for Intravascular Administration Sets 510(k).
- Flow rate test according to ISO 1135-4:2015.
- Blood leakage test in low pressure according to ISO 1135-4:2015 and ISO 8536-10:2015.
- Mechanical hemolysis (main line) according to ASTM F756-17 and ISO 10993-4.
- LAV Microbial Ingress Study according to AAMI/ISO CN27:2021 and FDA Guidance on Intravascular Administration Sets 510(k).
- Shelf-life package tests after sterilization, shipping simulation, and accelerated aging, including Sterilization (ISO 11137-2, ISO 11607-1), Shipping simulation (ISO 11607-1, ASTM D4169), Accelerated aging (ASTM F1980-16), and Packaging integrity tests (Bubble test per ASTM F2096, Burst test per ASTM F1140/F1140M, Peel test (manual) and visual test per ASTM F1886/F1886M, Peel test (mechanical) per ASTM F88/F88M, Dye test per ASTM F1929, Visual tests after pretreatments).
All performance tests were conducted successfully. No clinical study was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K11016
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2022
Elcam Medical ACAL % Tali Hazan Regulatory Affairs Consultant Talmed Ltd. Ramot-Naftali M.P Upper Galilee, 1383000 Israel
Re: K211204
Trade/Device Name: SafePort™ Manifold (or Stopcock) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FMG Dated: August 14, 2022 Received: August 16, 2022
Dear Tali Hazan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Wolloscheck, Ph.D. For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211204
Device Name SafePort(TM) Manifold (or Stopcock)
Indications for Use (Describe)
SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Elcam Medical. The logo features a stylized "E" symbol in orange and gray, followed by the words "Elcam" and "MEDICAL" stacked on top of each other in a dark gray sans-serif font. Below the words is the tagline "Where everything connects" in a smaller, lighter gray font.
K211204 510(k) Summary Elcam Medical's SafePort™ Manifold (or Stopcock)
1. Submitter Information
Elcam Medical ACAL Kibbutz Baram Merom HaGalil, 1386000, Israel Phone: +972-4-8988120 Fax: +972-(0)4-6980-777 Email: yaniv.m@elcam.co.il
Contact person name: Ms. Tali Hazan - RA Consultant, Talmed Ltd. Phone: +972-(0)505292304 Email: tali.hazan@talmed.co.il
2. Date of Preparation
September 15, 2022
3. Identification of Predicate Devices
- 3.1. Primary Predicate Device: Closed Swabable Stopcock and Minimal Residual Volume Luer-activated Swabable-stopcock, cleared under K060231 on April 13, 2006.
- 3.2. Reference Device: SafePort Manifold™ (or Stopcock), cleared under 510(k) number K11016 on June 09, 2011.
4. Identification of Subject Device
Regulatory Information Regulation Name: Intravascular administration set Regulation Number: 880.5440 Product Code: FMG Common Name: I.V. Set Stopcock Proprietary/Trade name: SafePort™ Manifold (or Stopcock)
5. Device Description
Elcam modified SafePort™ Manifold (also identified as SafePort™ Manifold) is used in Operating Room (OR) and Intensive Care Unit (ICU) to assist the physician and mainly the anesthesiologist in delivering IV drugs and fluids during and after operation.
Elcam's SafePort™ Manifold is designated for single use only (disposable) and its recommended maximal use duration is up to 24 hours.
Liquid compatibility: Elcam's SafePort™ Manifold is compatible with common fluids used in I.V. therapy, anesthesia and monitoring, including blood transfusion. The SafePort™ Manifold is made of a body with 1-5 side ports and 1-5 handles (depends on the number of ports).
..............................................................................................................................................................................
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Image /page/4/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" in orange and gray, followed by the words "Elcam" in bold, dark gray letters, stacked above the word "MEDICAL" in smaller, dark gray letters. Below the logo is the tagline "Where everything connects" in a smaller, lighter font.
Each port has a male or female connector (luer). Male connectors also include a nut (rotator) for locking over the female luer of the connected component. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock/Manifold body.
Operating mechanism is manual and simple operated by twisting the handle position to determine fluid direction.
Between each handle and port housing an Elastomer may be placed to function as a pressure Luer Activated Valve (LAV) as an option to standard open female luer. The LAV is welded to the manifold body's fluid line at the female side port(s) in order to avoid back flow (reflux) and to serve as closed port. A rotator is assembled on the proximal male port (which is connected toward the patient) in order to enable connection locking. The distal female port is connected to the I.V Set to accept the delivered drug or fluid. Open ports (female and male) may be provided with or without covers.
Design wise, the modified SafePort™ Manifold relies on Elcam legally marketed SafePort™ Manifold cleared under K111016 that was modified as follow:
The SafePort™ Handle was modified for better producibility: Elastomeric material was changed, a cone-shape was added to the handle stem at the sealing area, as well as "door" shape fluid entrance added instead of around the entire stem. Cosmetic/visual non-functional changes were also implemented. The SafePort™ Body was changed to fit the handle changes: The stopper, dimensions luer compliance with ISO 80369-7, side port LAV female thread connection improvements and cosmetic/visual changes. Additional green colorant was added to the existing Caps' colorants.
Transfusion use was added to the SafePort™ indications for use statement to align Elcam SafePort™ with all other Stopcock and Manifold products (as in the primary predicate device cleared under K060231) that share the same indications for use, basic fluid path design and material types. Labeling materials were revised to include the additional transfusion claim.
All modifications were evaluated using well-established tests' methods previously utilized by Elcam or conducted per FDA recognized consensus standards and provided as summary tabulated in a risk analysis format.
6. Indications for Use Statement
SafePort™ Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.
5
Image /page/5/Picture/0 description: The image is a logo for Elcam Medical. The logo features a stylized "E" made of orange and gray lines on the left. To the right of the "E" is the text "Elcam" in a dark gray sans-serif font, with "MEDICAL" in a smaller font below it. Underneath the logo is the tagline "Where everything connects" in a smaller, lighter font.
7. Summary of Substantial Equivalence:
In all aspects the modified device discussed in this 510(k) Submission, substantial equivalency was established with the predicate device, as can be demonstrated in the table below:
| Feature | Closed Swabable Stopcock
and Minimal Residual
Volume
Luer-activated Swabable-
stopcock (MRVLS)
Primary Predicate Device
(K060231) | SafePort™ Manifold (or
Stopcock) | Technological
Features Differences |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Elcam Closed Swabable
Stopcock and MRVLS is
indicated for fluid flow
directional control and for
providing access port(s) for
administration of solutions.
Typical uses include pressure
monitoring, intravenous fluid
administration and transfusion. | SafePort™ Manifold (or
Stopcock) is a one or more
multiple ports product, which is
indicated to serve as a flow
control and a conduit device for
I.V fluids delivery to the
patient's vascular system. The
product is intended for delivering
I.V drugs or fluids, allowing
gravity feed, sampling,
transfusion, bolus injection and
elimination of reflux of fluids
during operation. | Same indications for
use. Some
technological
differences are
discussed below. |
| Classification | Stopcock, I.V. Set, Product
Code: FMG,
Regulation Number: 880.5440,
Panel: General Hospital. | Stopcock, I.V. Set, Product
Code: FMG,
Regulation Number: 880.5440,
Panel: General Hospital. | No difference |
| Number of female
side ports | One or multiple
(according to the end user
request). | One or multiple (according to
the end user request). | No difference |
| Principle of
Operation | Manual twisting of handle.
with LAV on the side
port(s). | Manual twisting of handle
Two alternatives for operations:
with female luer on the side
ports or with LAV on the side
ports. | Same LAV on the side
port. Female ports were
tested for leakage and
luer tests per sec. 8.4,
8.5, 8.12 and 8.13
below. |
| Usage duration | Up to 24 hours | Up to 24 hours | No difference |
| Chemical
Resistance (Lipid) | Up to 24 hours | Up to 24 hours | No difference |
| Maximum
Pressure | Up to 2 bar (29 psi) | With LAV: Up to 2 bar (29 psi)
Standard Port: Up to 3 bar (45
psi) | 3 bar maximum
pressure was tested for
leakage test per sec. 8.4 |
| Feature | Closed Swabable Stopcock
and Minimal Residual
Volume
Luer-activated Swabable-
stopcock (MRVLS)
Primary Predicate Device | SafePort™ Manifold (or
Stopcock)
Subject Device | Technological
Features Differences |
| | (K060231) | | |
| Raw materials | Fluid line and ports (body
including rotator)
• Polysulfone
• Polycarbonate | Fluid line and ports (body
including rotator)
Polysulfone
Polycarbonate | No difference |
| | Handle
Polyethylene | Handle
Polyethylene with Elastomer | Handle elastomer tested
for biocompatibility, |
| | Handle's Elastomer is N/A for
this product's handle. | Handle's Elastomer
Green PE Thermoplast®. | torque and burst tests
per sec. 8.1, 8.2-8.3, and
8.7 below). |
| | Luer Activated valve (LAV)
• LAV's Cap:
Polycarbonate
• LAV's stem:
Lubricated blue
Liquid silicone
rubber | Luer Activated valve (LAV)
• LAV's Cap:
Polycarbonate
• LAV's stem:
Lubricated blue Liquid
silicone rubber | No difference |
| | Lubricant
Medical Silicone Fluid | Lubricant
Medical Silicone Fluid | No difference |
| | Port Covers (Caps)
Polypropylene | Port cover (Caps)
Polypropylene | No difference |
| | Colorants
• Light Blue
• Green
• Red
• White
• Yellow
• Blue | Colorants
• Light Blue
• Green
• Red
• White
• Yellow
• Green (additional hue) | Green additional hued
cap was evaluated for
biocompatibility per
sec. 8.1 below. |
| Material
biocompatibility | Biocompatible according to ISO
10993-1 standard. | Biocompatible according to ISO
10993-1 standard. | No difference |
| Materials
compatibility with
sterilization agents | Gamma irradiation and EtO | Gamma irradiation and EtO | No difference |
| Feature | Closed Swabable Stopcock
and Minimal Residual
Volume
Luer-activated Swabable-
stopcock (MRVLS)
Primary Predicate Device
(K060231) | SafePort™ Manifold (or
Stopcock)
Subject Device | Technological
Features Differences |
| Overall Shape | Body with side female closed
port (LAV), distal female port
and proximal male port;
Assembled Handle (with or
without MRVLS
design) | Same as primary predicate
device, except for certain
dimensional and visual
improvement which do not affect
device overall shape and
specification. | Differences were
evaluated for
dimensions, leakage
biocompatibility and
luer tests per sec. 8.1,
8.2-8.9, 8.12-8.13 and
8.15-8.17 below. |
| Shelf Life | 5 years | 3 years | Reduced shelf life, does
not affect safety and
effectiveness. |
| Device Sterilization
method | Gamma irradiation | Gamma irradiation | No difference |
Table 1: Substantial Equivalence (Comparison Table)
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Image /page/6/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" symbol in orange and gray, followed by the text "Elcam" in a dark gray sans-serif font. Below "Elcam" is the word "MEDICAL" in a smaller, bold, dark gray font. Underneath the logo is the tagline "Where everything connects" in a smaller, lighter gray font.
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Image /page/7/Picture/0 description: The image contains the logo for Elcam Medical. The logo consists of a stylized letter "E" in gray and orange, followed by the text "Elcam" in a dark gray sans-serif font. Below "Elcam" is the word "MEDICAL" in a similar font, but slightly smaller in size.
Substantial Equivalence Discussion and Conclusion:
The above comparison table demonstrates that Elcam's modified SafePort™ Manifold (or Stopcock) is the same as the primary predicate device in all key features and therefore, it was concluded by Elcam that it is substantial equivalent to the predicate device. In terms of the design changes, it should be noted that all changes to the SafePort™ took place to fit production processes and marketing preferences. No changes took place to the subject device's basic specifications and testing methods. Acceptance criteria of all tests but one remained the same. A difference of 1.5 PSI in the upper limit of the handle door burst pressure was concluded as non-sensible during clinical use and therefore does not affect the device safety and effectiveness and does not alter substantial equivalence criteria.
Like the primary predicate device, the subject device has the same indications for use, including the transfusion which was added to the modified SafePort™. Both devices rely on same or highly similar technology and are classified under same classification.
Certain differences between the subject device and the primary predicate device, do not affect the device safety and effectiveness and have been further supported by the above identified reference device. These differences are hereby discussed:
The handle elastomer exist in the modified SafePort™ does not exist in the primary predicate device. While the subject device contains side female port(s) with or without swabable port(s), the primary predicate device contains only swabable side port(s). The reference device was used to leverage test methods for these features.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Image /page/8/Picture/0 description: The image is a logo for Elcam Medical. The logo features a stylized "E" made of gray and orange lines on the left. To the right of the "E" is the text "Elcam" in a dark gray sans-serif font, with the word "MEDICAL" below it in a smaller font. Below the text is the tagline "Where everything connects" in a smaller, lighter font.
The subject SafePort™ raw materials change (different elastomer grade and additional green colorant), and the design changes to the body, handle and LAV's cap, do not alter the basic shape of the device, did not raise new risks and were validated accordingly within the existing well-established specifications, test methods and acceptance criteria as discussed and presented in the 510(k) submission. Therefore, it was concluded that these changes do not affect the safety and effectiveness of the modified SafePort.
In terms of shelf life, so far, Elcam has validated the modified SafePort™ for three years which is less than the predicate device that was validated for 5 years. This difference narrows the claimed shelf life and therefore does not alter the safety and effectiveness of the modified device.
All other features as indicated in the comparison table, remains exactly the same as the predicate device.
In light of the above, it was concluded that the modified SafePort™ Manifold is substantially equivalent to its primary predicate device.
8. Non-Clinical Performance Testing
Performance tests were conducted successfully by Elcam in order to validate the changes presented in this 510(k) Submission using well established methods based either on recognized consensus standards or Elcam's internal existing test methods previously utilized for legally marketed devices. No deviations took place during the tests. The tests were as follows:
- 8.1. Biocompatibility tests were performed according to ISO 10993-1:2018 recognized consensus standard and additional parts for each test in conjunction with most current FDA's Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". All tests were performed on final-sterile devices. The biocompatibility tests that were conducted are:
- Cytotoxicity per ISO 10993-5:2009. 8.1.1.
- Maximization Sensitization per ISO 10993-10:2010. 8.1.2.
- 8.1.3. Intracutaneous Study per ISO 10993-10:2010.
- 8.1.4. Acute Systemic Toxicity per ISO 10993-11:2017.
- 8.1.5. Pyrogen Study - Material-Mediated per ISO 10993-11:2017.
- 8.1.6. Hemolysis per ISO 10993-4:2017.
- Complement Activation per ISO 10993-4:2017. 8.1.7.
- 8.1.8. Partial Thromboplastin Time (PTT) per ISO 10993-4:2017.
- 8.1.9. Platelet Activation per ISO 10993-4:2017.
- Initial handle torque test was conducted using method based on Elcam internal protocol 8.2. as previously used for Elcam cleared I&S Manifold (K032393).
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Image /page/9/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized letter "E" in orange and gray, followed by the words "Elcam" and "MEDICAL" stacked on top of each other in a dark gray color. Below the logo is the tagline "Where everything connects" in a smaller, lighter gray font.
- 8.3. Handle stopper torque (override) test was conducted using method based on Elcam internal protocol as previously used for Elcam cleared SafePort™ Manifold (K111016).
- 8.4. Leakage tests using pressure of 200 kPa (2 bar) and 300 kPa (3 bar) were conducted according to recognized consensus standard ISO 8536-10:2015.
- Leakage test using pressure of 50 kPa, (0.5 bar) was conducted according to recognized 8.5. consensus standard ISO 8536-10:2015.
- 8.6. Vacuum test was conducted according to recognized consensus standard ISO 8536-4:2010.
- 8.7. Handle "door" burst pressure test was conducted using method based on Elcam internal protocol as previously used for Elcam cleared SafePort™ Manifold (K111016).
- 8.8. Chemical resistance test (Lipid resistance) for 24 hours was conducted using method based on Elcam internal protocol as previously used for Elcam cleared SafePort™ Manifold (K111016).
- Flow rate test was conducted according to recognized consensus standard ISO 8536-8.9. 4:2010.
- 8.10. Particulate contamination test was conducted according to recognized consensus standard ISO 8536-4:2010.
- 8.11. Subvisible Particulate Matter test was conducted, according to USP .
- 8.12. Luer tests were conducted according to recognized consensus standards ISO 80369-7:2016 and ISO 80369-20:2015 as follows:
- 8.12.1. Positive pressure liquid leakage.
- 8.12.2. Sub-atmospheric pressure air leakage.
- 8.12.3. Stress cracking.
- 8.12.4. Resistance to separation from axial load.
- 8.12.5. Resistance to separation from unscrewing.
- 8.12.6. Resistance to overriding.
- 8.13. Luer dimensions measurement was conducted using method based on Elcam internal protocol as previously used for Elcam cleared Stopcocks and Manifolds.
- 8.14. LAV cap wiping effectiveness was conducted according to AAMI TIR30:2011/(R)2016 standard, ISO 11737-1:2018 recognized consensus standard and with most current FDA's Guidance for Intravascular Administration Sets 510(k) submission.
- 8.15. Flow rate test was conducted according to recognized consensus standard ISO 1135-4:2015.
- 8.16. Blood leakage test in low pressure was conducted according to both ISO 1135-4:2015 and ISO 8536-10:2015 recognized consensus standards.
- 8.17. Mechanical hemolysis (main line) of the SafePort™ was conducted according to recognized consensus standards ASTM F756-17 and ISO 10993-4.
- 8.18. LAV Microbial Ingress Study was conducted in accordance with AAMI/ISO CN27:2021 and FDA Guidance on Intravascular Administration Sets 510(k), dated July 11, 2008.
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Image /page/10/Picture/0 description: The image shows the logo for Elcam Medical. The logo consists of a stylized "E" shape in orange and gray, followed by the text "Elcam" in a dark gray, sans-serif font. Below "Elcam" is the word "MEDICAL" in a smaller, dark gray, sans-serif font. Underneath the text is the tagline "Where everything connects" in a smaller, lighter gray font.
- 8.19. Shelf-life package tests were conducted after sterilization, shipping simulation and accelerated aging, as follows:
- 8.19.1. Sterilization, per ISO 11137-2 and ISO 11607-1.
- 8.19.2. Shipping simulation on worst case configuration, per ISO 11607-1 and ASTM D4169.
- 8.19.3. Accelerated aging, simulating the claimed shelf-life, per ASTM F1980-16.
- 8.19.4. Packaging integrity tests after shipping simulation and Gamma sterilization were successfully conducted as follows:
- a) Bubble test, per ASTM F2096
- b) Burst test, per ASTM F1140/F1140M
- c) Peel test (manual) and a visual test after peeling, per ASTM F1886/F1886M.
- d) Peel test (mechanical), per ASTM F88/F88M.
- e) Dye test, per ASTM F1929.
- Visual tests after pretreatments (shipping, accelerated aging and gamma f) sterilization), per Elcam internal procedure.
9. Clinical Test Conclusion
No clinical Study was performed for the purpose of this submission.
10. Substantially Equivalent (SE) Conclusion
After discussing substantial equivalency of the modified SafePort™ with its predicate device in terms of similarities and differences, intended use, and technological characteristics, it was concluded that none of the changes altered the device safety and effectiveness and that the criteria of substantial equivalence is met. The evaluation of the subject device performance tests also demonstrated that it is as safe and as effective as the legally marketed predicate devices and therefore substantial equivalent.