(305 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fluid dynamics, with no mention of AI/ML algorithms, data processing, or learning capabilities.
Yes
The device is intended to aid in the reduction of peripheral IV mechanical complications requiring IV replacement, which is a therapeutic purpose.
No
The device is described as a tension-activated accessory that separates to close the flow path when excessive tension acts on the IV tubing. Its intended use is to aid in the reduction of peripheral IV mechanical complications. It performs a mechanical function of interruption, rather than diagnosing a condition or providing information about a patient's health.
No
The device description clearly indicates it is a physical accessory that connects to existing IV sets and separates under tension, which is a hardware function. The performance studies also focus on physical properties and testing of a tangible device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intended Use of the Orchid SRV: The intended use of the Orchid SRV is to be placed in the IV line to prevent mechanical complications from tension. It is a physical accessory that interacts with the IV tubing and flow, not with a specimen from the patient's body for diagnostic purposes.
- Device Description: The device description details its mechanical function and connection to the IV system, not any process involving analyzing biological samples.
- Performance Studies: The performance studies listed focus on the mechanical integrity, flow characteristics, sterility, and biocompatibility of the device itself, not on its ability to analyze biological samples or provide diagnostic information.
The Orchid SRV is a medical device used in the administration of IV fluids, but it does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent and continuous infusion.
The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.
The Orchid SRV™ is for use with patients eighteen (18) years of age and older.
Product codes (comma separated list FDA assigned to the subject device)
QOI
Device Description
The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window (between 1-4.2 lbf), automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
eighteen (18) years of age and older.
Intended User / Care Setting
Physician or clinical personnel with clearance to administer IV sets and related products; Hospital
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)
The following performance data was considered in support of the substantial equivalence determination.
The following tests were performed to demonstrate that the proposed Orchid Safety Release ValveTM met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.
Performance Testing:
- Usability Testing
- Functional Testing:
- o Tensile Strength Testing (ISO 8536-4 A-3)
- Air Leakage Device Not Activated (ISO 80369-20:2015 Annex D) O
- Force to Disconnect O
- Air Leakage Device Activated (ISO 80369-20:2015 Annex D) O
- Water Leakage Device Not Activated (ISO 80369-20:2015 Annex C) O
- Water Leakage Female (ISO 80369-20:2015 Annex C) O
- Water Leakage Male (ISO 80369-20:2015 Annex C) o
- Flow Rate O
- Re-assembly Prevention o
- Assembly Weight O
- Particulate Testing (USP )
- Luer Lock Testing (ISO 80369-7:2016)
- Microbial Ingress Testing
- Clinical Simulation Testing
Sterilization:
The Orchis SRV is provided sterile and is sterilized with Ethylene Oxide. The following testing was performed:
- Packaging and Sterilization Testing (ASTM D4169-16, ASTM F88/F88M-15, ASTM F1886/F1886M-16, ATM F2069-11)
- Shelf-Life Testing (ASTM F1980-16)
- Bacterial Endotoxin Testing .
The sterilization validation followed the guidelines in the Product Adoption and Process Equivalence for Ethylene Oxide Sterilization AAMI TIR28:2016. The sterilization process has been validated per ISO 14937:2009 using the half dose method. The overkill approach was used to ensure a sterility assurance level (SAL) of 10^-6 was achieved.
Biocompatibility:
Biocompatibility testing was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The proposed Orchid Safety Release Valve™ is considered an externally communicating, prolonged exposure device that indirectly contacts the blood path. Therefore, the following tests are required:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Irritation/Intracutaneous Reactivity (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
- Material-Mediated Pyrogenicity (ISO 10993-11:2017)
- Subacute/Subchronic Toxicity (ISO 10993-11:2017)
- Haemocompatibility (ISO 10993-4:2017)
Based on the results of the biocompatibility testing performed on the final Orchid Safety Release Valve™, the SRV meets the requirements outlined in ISO 10993-1:2018.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5220 Intravenous catheter force-activated separation device.
(a)
Identification. An intravenous catheter force-activated separation device is placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must be provided to demonstrate clinically acceptable performance for the intended use of the device.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Separation force testing;
(ii) Validation of anti-reconnect features;
(iii) Air and liquid leakage testing, both before and after separation;
(iv) Luer connection testing;
(v) Flow rate testing;
(vi) Particulate testing; and
(vii) Microbial ingress testing.
(3) The device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate that the device is sterile and non-pyrogenic.
(5) Performance testing must support the shelf life of the device by demonstrating continued sterility and device functionality over the identified shelf life.
(6) Device labeling must include:
(i) Instructions for use; and
(ii) A discussion of catheter dressings intended to be used with the device.
0
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Linear Health Sciences, LLC % Jessica Czamanski Project Engineer RQM+ 2790 Mosside Blvd #800 Monroeville, Pennsylvania 15146
Re: K212064
Trade/Device Name: Orchid Safety Release Valve™ Regulation Number: 21 CFR 880.5220 Regulation Name: Intravenous Catheter Force-Activated Separation Device Regulatory Class: Class II Product Code: QOI Dated: March 8, 2022 Received: March 9, 2022
Dear Jessica Czamanski:
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 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
1
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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212064
Device Name Orchid Safety Release Valve(TM)
Indications for Use (Describe)
The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRVTM is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRVTM is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRVTM separates and closes the flow path in both directions. The Orchid SRVTM can be used during intermittent and continuous infusion.
The Orchid SRVTM is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.
The Orchid SRVTM is for use with patients eighteen (18) years of age and older.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Linear Health Sciences. The logo is in blue and gray. The word "LINEAR" is in blue, and the words "HEALTH SCIENCES" are in gray and are located below the word "LINEAR". There is a trademark symbol to the right of the word "LINEAR".
510(k) SUMMARY
K212064
This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.
Submitter l.
| Submitter's Name: | Linear Health Sciences, LLC |
|---|---|
| Contact Person: | Mr. Daniel Clark |
| President | |
| Address: | 5333 Wisteria Drive Oklahoma |
| City, OK 73142 | |
| Telephone: | (310) 721-6222 |
| Email: | dan.clark@linearsciences.com |
| Date Preparation: | April 4, 2022 |
II. Application Correspondent
| Contact's Name: | RQM+ |
|---|---|
| Contact Person: | Jessica Czamanski |
| Project Engineer, Regulatory Consultant | |
| Address: | 2790 Mosside Blvd #800 |
| Monroeville, PA 15146 | |
| Telephone: | (412) 816-8147 |
| Email: | jczamanski@rqmplus.com |
III. Subject Device
| Trade Name: | Orchid Safety Release Valve™ |
|---|---|
| Common Name: | Quick Disconnect Accessory |
| Classification Name: | Intravenous Catheter Force-Activated Separation Device |
| Product Classification: | Class II |
| Regulation Number: | 21 CFR §880.5220 |
| Product Code: | QOI |
IV. Predicate Device
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Image /page/4/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is written in blue, with the "I" in "LINEAR" being stylized as a vertical line with a small square on top. Below "LINEAR" is the text "HEALTH SCIENCES" in gray. To the right of the word "LINEAR" is the trademark symbol.
| Manufacturer: | Site Saver, Inc. d/b/s Lineus Medical |
|---|---|
| Device Name: | SafeBreak® Vascular |
| 510(k) Number: | DEN190043 |
| Product Classification: | Class II |
| Regulation Number: | 21 CFR §880.5220 |
V. Device Description
The Orchid Safety Release Valve™ or Orchid SRV™ connects via standard luer-locking connection, allowing flow during IV therapy. The Orchid SRV™ is designed to allow the device to separate into two halves when longitudinal tension exceeds the SRV tension window (between 1-4.2 lbf), automatically closing the flow path to both IV extension set and IV administration set. Following separation, a component of the Orchid SRV™ is left attached to each side of the infusion system to protect the intraluminal pathway. Upon separation, replacement of the SRV™ is necessary. Follow institutional policy to replace the SRV™, or at least every seven (7) days.
VI. Intended Use
The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory, provided sterile and for single use, in line with an IV administration set and peripheral IV extension set on a patient. The Orchid SRV™ provides a quick separation feature that allows the device to quickly separate into two halves upon tension, closing the flow path to prevent leakage. The device is intended to reduce the risk of IV catheter failure, requiring IV catheter replacement.
VII. Indications for Use
The Linear Health Sciences™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension set connection. The Orchid SRV™ is intended for use with electronic IV pumps in peripheral IV catheter applications where tension may act on the IV tubing. The Orchid SRV™ is designed to allow flow to an IV catheter. When excessive tension acts on the line, the Orchid SRV™ separates and closes the flow path in both directions. The Orchid SRV™ can be used during intermittent and continuous infusion.
The Orchid SRV™ is intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement.
The Orchid SRV™ is for use with patients eighteen (18) years of age and older.
VIII. Comparison of Technological Characteristics with the Predicate Devices
The subject and predicate devices are accessories that allow separation by force-activation used in infusion and/or IV administration. Both devices are intended to be connected via standard luer lock mechanisms. Both devices have intended use, same material types, similar technological characteristics, and same operating principle. Although the difference in technological characteristics is specific to the force required for separation of the two halves of each device performs according to its own specifications. Both devices are intended to aid in reduction of the occurrence of dislodgement, therefore, the difference in technology do not affect the safety and effectiveness of the device and is substantially equivalent.
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Image /page/5/Picture/0 description: The image shows the logo for Linear Health Sciences. The logo is blue and consists of the word "LINEAR" in large, bold letters, with a small "TM" symbol in the upper right corner. Below the word "LINEAR" are the words "HEALTH SCIENCES" in smaller, gray letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.
The following table (Table 5-1) provides an overview of general technological characteristics in comparison to the predicate device.
| Product
Features | Subject
Linear Health Sciences'
Orchid Safety Release
Valve™
(K212064) | Predicate
Site Saver, Inc./ Lineus
Medical
SafeBreak Vascular
(DEN190043) | Substantial
Equivalence
Determination |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | -same- | |
| Product Code | QOI | -same- | |
| Regulation
Number | 21 CFR §880.5220 | -same- | |
| Device
Classification
Name | Intravenous Catheter
Force-Activated
Separation Device | -same- | |
| Indications for
Use | The Linear Health
Sciences™ Orchid Safety
Release Valve™ is a
tension-activated
accessory for single
patient use and placed
between the existing IV
administration set and IV
extension set connection.
The Orchid SRV™ is
intended for use with
electronic IV pumps in
peripheral IV catheter
applications where tension
may act on the IV tubing.
The Orchid SRV™ is
designed to allow flow to
an IV catheter. When
excessive tension acts on
the line, the Orchid SRV™
separates and closes the
flow path in both
directions. The Orchid
SRV™ can be used during
intermittent infusion and
continuous infusion.
The Orchid SRV™ is
intended to aid in
reduction of peripheral IV
mechanical complications
requiring IV replacement.
The Orchid SRV™ is for
use with patients eighteen
(18) years of age and
older. | SafeBreak® Vascular is
intended to separate
when excessive tension
is exerted across a
peripheral IV
administration set. When
SafeBreak® Vascular
separates, fluid flow is
stopped from the
infusion pump and blood
flow is stopped from the
patient's IV catheter.
SafeBreak® Vascular is
intended to aid in
reduction of peripheral
IV mechanical
complications requiring
IV replacement.
SafeBreak® Vascular is
intended to be used on
peripheral IV catheters
in adults and adolescent
populations eighteen
(18) years of age and
older receiving
intermittent or
continuous infusions
with an electronic pump. | The subject and
predicate devices
are intended to
reduce
dislodgement
during IV infusion.
However, the
Orchid SRV has a
lower separation
force, which allows
the device to
prevent
dislodgement when
using securement
methods that have
lower pull forces. |
| Table 5-1: General Technological Characteristics Comparison | | | |
| Product
Features | Subject
Linear Health Sciences'
Orchid Safety Release
Valve™
(K212064) | Predicate
Site Saver, Inc./ Lineus
Medical
SafeBreak Vascular
(DEN190043) | Substantial
Equivalence
Determination |
| Environment of
Use | Hospital | -same- | |
| Provided Sterile | Yes | -same- | |
| Principle of
Operation | The Orchid Safety
Release Valve™ has luer
lock connections that will
lock the device in place
during use. The female
luer connects to an
administration set while
the male luer connects to
a vascular access device
hub or extension set. Once
connected the device
allows for continuous flow.
The Orchid SRV will
separate into the male and
female subassemblies,
upon a tension event,
automatically closing the
flow path, while
maintaining sterility and
preventing fluid leakage
form the device. | The SafeBreak Vascular
connects to the
needleless connector
found in the existing IV
extension set and to the
existing IV
administration set via
luer connectors. Upon
installation of the
SafeBreak Vascular,
infusion can occur. Upon
tension the SafeBreak
Vascular separates and
the valve on each end of
the device closes,
stopping flow. | The principle of
operation for the
subject and
predicate devices is
the same. |
| User Profile | Physician or clinical
personnel with clearance
to administer IV sets and
related products | -same- | |
| Separation
Force | 1-4.2 lbf | 4 ± 1 lbf | The lower limit of the
Orchid Safety
Release Valve's
separation force of 1-
4.2 lbf was
specifically designed
to provide subject
device separation
prior to securement
device failure even for
those securement
devices that come in
at the lower end of
the pull force
spectrum. Some
medical adhesives
are specifically
formulated to require
a lower pull force due
to the usage on
elderly, fragile skin, or |
| | | | those at risk of
increased IV
dislodgement. The
Orchid SRV's use
specifications that
work across the low
end of the range
provide benefit to
these patients.
Performance
testing performed
to demonstrate
that device
conforms to
specification. |
| Vascular access
Catheter Type | Peripheral catheter | -same- | |
| For Use with
Electronic
Pump | Yes | -same- | |
| Single Use | Yes | -same- | |
| Continuous and
Intermittent
Infusion | Yes | -same- | |
Table 5-1: General Technological Characteristics Comparison
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Image /page/6/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue, sans-serif font, with a small "TM" symbol in the upper right corner. Below "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray, sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for Linear Health Sciences. The logo is blue and consists of the word "LINEAR" in large, bold letters, with the "I" in "LINEAR" replaced by a vertical line. Below the word "LINEAR" are the words "HEALTH SCIENCES" in smaller, gray letters. There is a trademark symbol to the right of the word "LINEAR".
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Image /page/8/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue, sans-serif font, with a small trademark symbol in the upper right corner. Below the word "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray, sans-serif font.
| Product
Features | Subject
Linear Health Sciences'
Orchid Safety Release
Valve™
(K212064) | Predicate
Site Saver, Inc./ Lineus
Medical
SafeBreak Vascular
(DEN190043) | Substantial
Equivalence
Determination |
|---------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Sterilization | Ethylene Oxide | -same- | |
| SAL | $10^{-6}$ | -same- | |
IX. Performance Data
The following performance data was considered in support of the substantial equivalence determination.
The following tests were performed to demonstrate that the proposed Orchid Safety Release Valve™ met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.
Performance Testing
- Usability Testing ●
- Functional Testing:
- o Tensile Strength Testing (ISO 8536-4 A-3)
- Air Leakage Device Not Activated (ISO 80369-20:2015 Annex D) O
- Force to Disconnect O
- Air Leakage Device Activated (ISO 80369-20:2015 Annex D) O
- Water Leakage Device Not Activated (ISO 80369-20:2015 Annex C) O
- Water Leakage Female (ISO 80369-20:2015 Annex C) O
- Water Leakage Male (ISO 80369-20:2015 Annex C) o
- Flow Rate O
- Re-assembly Prevention o
- Assembly Weight O
- Particulate Testing (USP )
- Luer Lock Testing (ISO 80369-7:2016)
- Microbial Ingress Testing ●
- . Clinical Simulation Testing
Sterilization
.
The Orchis SRV is provided sterile and is sterilized with Ethylene Oxide. The following testing was performed:
- Packaging and Sterilization Testing (ASTM D4169-16, ASTM F88/F88M-15, ASTM ● F1886/F1886M-16, ATM F2069-11)
- Shelf-Life Testing (ASTM F1980-16)
- Bacterial Endotoxin Testing .
The sterilization validation followed the guidelines in the Product Adoption and Process Equivalence for Ethylene Oxide Sterilization AAMI TIR28:2016. The sterilization process has been validated per ISO 14937:2009 using the half dose method. The overkill approach was used to ensure a sterility assurance level (SAL) of 10-6 was achieved.
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Image /page/9/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue, sans-serif font, with a small "TM" symbol in the upper right corner. Below "LINEAR" in a smaller, gray, sans-serif font are the words "HEALTH SCIENCES."
Biocompatibility
Biocompatibility testing was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The proposed Orchid Safety Release Valve™ is considered an externally communicating, prolonged exposure device that indirectly contacts the blood path. Therefore, the following tests are required:
- Cytotoxicity (ISO 10993-5:2009) ●
- . Sensitization (ISO 10993-10:2010)
- Irritation/Intracutaneous Reactivity (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
- Material-Mediated Pyrogenicity (ISO 10993-11:2017) .
- Subacute/Subchronic Toxicity (ISO 10993-11:2017) ●
- Haemocompatibility (ISO 10993-4:2017) .
Based on the results of the biocompatibility testing performed on the final Orchid Safety Release Valve™, the SRV meets the requirements outlined in ISO 10993-1:2018.
X. Conclusion
The proposed Orchid Safety Release Valve™ has the same intended use, environment of use, operating principle and fundamental technology, and similar materials as the predicate device. Any differences in the technological characteristics do not raise any new questions or concerns of safety and effectiveness. The information provided in this submission demonstrates that the subject device is substantially equivalent to its predicate.