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.

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.

AI/ML Overview

The SafePort™ Manifold (or Stopcock) is a medical device used for flow control and fluid delivery in IV therapy. Based on the provided document, the device did not undergo clinical studies, therefore, there is no information about reader studies, effect sizes, training sets, or expert qualifications. The performance data is derived from non-clinical laboratory testing.

Here's the summary of the acceptance criteria and device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to a predicate device and lists various non-clinical performance tests. The acceptance criteria for most tests remained the same as previously established. A specific difference in handle door burst pressure is noted but deemed clinically non-sensible. Since specific numerical acceptance criteria are not provided for all tests, the table below will describe the test and the reported outcome.

Test Category	Acceptance Criteria (Internal/Standard)	Reported Device Performance
Biocompatibility (ISO 10993-1, -4, -5, -10, -11)	Standard per ISO 10993 series and FDA Guidance	All tests performed successfully on final-sterile devices (Cytotoxicity, Maximization Sensitization, Intracutaneous Study, Acute Systemic Toxicity, Pyrogen Study, Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Platelet Activation).
Initial Handle Torque Test	Based on internal protocol (K032393)	Performed successfully.
Handle Stopper Torque (Override) Test	Based on internal protocol (K111016)	Performed successfully.
Leakage Tests (200 kPa / 2 bar & 300 kPa / 3 bar)	Recognized standard ISO 8536-10:2015	Performed successfully. (Note: 3 bar maximum pressure tested for standard port, predicate was 2 bar).
Leakage Test (50 kPa / 0.5 bar)	Recognized standard ISO 8536-10:2015	Performed successfully.
Vacuum Test	Recognized standard ISO 8536-4:2010	Performed successfully.
Handle "Door" Burst Pressure Test	Based on internal protocol (K111016). (Note: 1.5 PSI difference from predicate, but deemed clinically insignificant)	Performed successfully.
Chemical Resistance (Lipid) for 24 hours	Based on internal protocol (K111016)	Performed successfully.
Flow Rate Test (ISO 8536-4:2010)	Recognized standard ISO 8536-4:2010	Performed successfully.
Particulate Contamination Test	Recognized standard ISO 8536-4:2010	Performed successfully.
Subvisible Particulate Matter Test	USP <788>	Performed successfully.
Luer Tests (ISO 80369-7:2016 & ISO 80369-20:2015)	Recognized standards ISO 80369-7 and ISO 80369-20	Performed successfully (Positive pressure liquid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding).
Luer Dimensions Measurement	Based on internal protocol for Stopcocks and Manifolds	Performed successfully.
LAV Cap Wiping Effectiveness	AAMI TIR30:2011/(R)2016, ISO 11737-1:2018, FDA Guidance	Performed successfully.
Flow Rate Test (ISO 1135-4:2015)	Recognized standard ISO 1135-4:2015	Performed successfully.
Blood Leakage Test in Low Pressure	Recognized standards ISO 1135-4:2015 and ISO 8536-10:2015	Performed successfully.
Mechanical Hemolysis (main line)	Recognized standards ASTM F756-17 and ISO 10993-4	Performed successfully.
LAV Microbial Ingress Study	AAMI/ISO CN27:2021 and FDA Guidance	Performed successfully.
Shelf-life Package Tests	ISO 11137-2, ISO 11607-1, ASTM D4169, ASTM F1980-16, ASTM F2096, ASTM F1140/F1140M, ASTM F1886/F1886M, ASTM F88/F88M, ASTM F1929	Performed successfully after sterilization, shipping simulation, and accelerated aging. Included bubble, burst, peel (manual and mechanical), dye, and visual tests. Note: Validated shelf life for 3 years, compared to predicate's 5 years.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each non-clinical test. It mentions that "Performance tests were conducted successfully by Elcam in order to validate the changes presented in this 510(k) Submission using well established methods." These are laboratory tests conducted by the manufacturer, Elcam Medical ACAL, based in Kibbutz Baram, Merom HaGalil, Israel. The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the document explicitly states: "No clinical Study was performed for the purpose of this submission." The evaluation relies on non-clinical performance testing against recognized standards and internal protocols, not expert-derived ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical study or human reader evaluation was performed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission is based on non-clinical performance testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This information is not applicable. The device is a physical medical device (SafePort™ Manifold or Stopcock) and not an AI algorithm.

7. The Type of Ground Truth Used

For non-clinical performance testing, the "ground truth" is defined by adherence to established, recognized consensus standards (e.g., ISO, ASTM, USP, AAMI TIR) and Elcam's internal, previously validated test methods and specifications. These standards provide objective criteria for device performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI algorithm.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K211204

Device Name SafePort(TM) Manifold (or Stopcock)

Indications for Use (Describe)

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's SafePort™ Manifold is designated for single use only (disposable) and its recommended maximal use duration is up to 24 hours.

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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.

Operating mechanism is manual and simple operated by twisting the handle position to determine fluid direction.

Design wise, the modified SafePort™ Manifold relies on Elcam legally marketed SafePort™ Manifold cleared under K111016 that was modified as follow:

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.

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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 Stopcockand Minimal ResidualVolumeLuer-activated Swabable-stopcock (MRVLS)Primary Predicate Device(K060231)	SafePort™ Manifold (orStopcock)	TechnologicalFeatures Differences
Indication for use	Elcam Closed SwabableStopcock and MRVLS isindicated for fluid flowdirectional control and forproviding access port(s) foradministration of solutions.Typical uses include pressuremonitoring, intravenous fluidadministration and transfusion.	SafePort™ Manifold (orStopcock) is a one or moremultiple ports product, which isindicated to serve as a flowcontrol and a conduit device forI.V fluids delivery to thepatient's vascular system. Theproduct is intended for deliveringI.V drugs or fluids, allowinggravity feed, sampling,transfusion, bolus injection andelimination of reflux of fluidsduring operation.	Same indications foruse. Sometechnologicaldifferences arediscussed below.
Classification	Stopcock, I.V. Set, ProductCode: FMG,Regulation Number: 880.5440,Panel: General Hospital.	Stopcock, I.V. Set, ProductCode: FMG,Regulation Number: 880.5440,Panel: General Hospital.	No difference
Number of femaleside ports	One or multiple(according to the end userrequest).	One or multiple (according tothe end user request).	No difference
Principle ofOperation	Manual twisting of handle.with LAV on the sideport(s).	Manual twisting of handleTwo alternatives for operations:with female luer on the sideports or with LAV on the sideports.	Same LAV on the sideport. Female ports weretested for leakage andluer tests per sec. 8.4,8.5, 8.12 and 8.13below.
Usage duration	Up to 24 hours	Up to 24 hours	No difference
ChemicalResistance (Lipid)	Up to 24 hours	Up to 24 hours	No difference
MaximumPressure	Up to 2 bar (29 psi)	With LAV: Up to 2 bar (29 psi)Standard Port: Up to 3 bar (45psi)	3 bar maximumpressure was tested forleakage test per sec. 8.4
Feature	Closed Swabable Stopcockand Minimal ResidualVolumeLuer-activated Swabable-stopcock (MRVLS)Primary Predicate Device	SafePort™ Manifold (orStopcock)Subject Device	TechnologicalFeatures Differences
	(K060231)
Raw materials	Fluid line and ports (bodyincluding rotator)• Polysulfone• Polycarbonate	Fluid line and ports (bodyincluding rotator)PolysulfonePolycarbonate	No difference
	HandlePolyethylene	HandlePolyethylene with Elastomer	Handle elastomer testedfor biocompatibility,
	Handle's Elastomer is N/A forthis product's handle.	Handle's ElastomerGreen PE Thermoplast®.	torque and burst testsper sec. 8.1, 8.2-8.3, and8.7 below).
	Luer Activated valve (LAV)• LAV's Cap:Polycarbonate• LAV's stem:Lubricated blueLiquid siliconerubber	Luer Activated valve (LAV)• LAV's Cap:Polycarbonate• LAV's stem:Lubricated blue Liquidsilicone rubber	No difference
	LubricantMedical Silicone Fluid	LubricantMedical 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 huedcap was evaluated forbiocompatibility persec. 8.1 below.
Materialbiocompatibility	Biocompatible according to ISO10993-1 standard.	Biocompatible according to ISO10993-1 standard.	No difference
Materialscompatibility withsterilization agents	Gamma irradiation and EtO	Gamma irradiation and EtO	No difference
Feature	Closed Swabable Stopcockand Minimal ResidualVolumeLuer-activated Swabable-stopcock (MRVLS)Primary Predicate Device(K060231)	SafePort™ Manifold (orStopcock)Subject Device	TechnologicalFeatures Differences
Overall Shape	Body with side female closedport (LAV), distal female portand proximal male port;Assembled Handle (with orwithout MRVLSdesign)	Same as primary predicatedevice, except for certaindimensional and visualimprovement which do not affectdevice overall shape andspecification.	Differences wereevaluated fordimensions, leakagebiocompatibility andluer tests per sec. 8.1,8.2-8.9, 8.12-8.13 and8.15-8.17 below.
Shelf Life	5 years	3 years	Reduced shelf life, doesnot affect safety andeffectiveness.
Device Sterilizationmethod	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 <788>.
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.

Regulation Number and Section

§ 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.