(305 days)
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.
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.
The provided text describes the Orchid Safety Release Valve™ (Orchid SRV™), a medical device intended to reduce peripheral IV mechanical complications. The information focuses on its substantial equivalence to a predicate device (SafeBreak® Vascular) and outlines various performance and safety tests.
Here's a breakdown of acceptance criteria and associated study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Subject Device (Orchid Safety Release Valve™) Performance | Predicate Device (SafeBreak® Vascular) Performance (for comparison) | Substantial Equivalence Determination / Comment |
|---|---|---|---|
| Intended Use | Tension-activated accessory for single patient use, placed between IV administration set and IV extension set connection. Designed to allow flow, separate and close flow path in both directions when excessive tension acts on the line. Intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. For use with patients 18 years and older. | Separates when excessive tension is exerted across a peripheral IV administration set. Stops fluid flow from infusion pump and blood flow from patient's IV catheter. Intended to aid in reduction of peripheral IV mechanical complications requiring IV replacement. For use on peripheral IV catheters in adults and adolescent populations 18 years and older receiving intermittent or continuous infusions with an electronic pump. | Same intended use; subject device has a lower separation force designed to prevent dislodgement with lower pull-force securement methods. |
| Separation Force | 1-4.2 lbf | 4 ± 1 lbf | The lower limit of the Orchid SRV's separation force (1-4.2 lbf) was specifically designed to provide separation prior to securement device failure, even for securement devices with lower pull forces used for fragile skin. Performance testing demonstrated device conforms to this specification. |
| Functional Testing | - Tensile Strength Testing (ISO 8536-4 A-3) - Air Leakage Device Not Activated (ISO 80369-20:2015 Annex D) - Force to Disconnect - Air Leakage Device Activated (ISO 80369-20:2015 Annex D) - Water Leakage Device Not Activated (ISO 80369-20:2015 Annex C) - Water Leakage Female (ISO 80369-20:2015 Annex C) - Water Leakage Male (ISO 80369-20:2015 Annex C) - Flow Rate - Re-assembly Prevention - Assembly Weight - Particulate Testing (USP <788>) | Not explicitly stated in the comparison table, but implied similar functionalities. | These tests were performed to demonstrate that the proposed Orchid SRV™ met applicable design and performance requirements. |
| Usability Testing | Performed | Not specified | Performed. |
| Clinical Simulation Testing | Performed | Not specified | Performed. |
| Sterilization | Ethylene Oxide, SAL 10⁻⁶ | Ethylene Oxide, SAL 10⁻⁶ | Same. Sterilization validation followed AAMI TIR28:2016 and ISO 14937:2009 (half dose method, overkill approach). |
| Biocompatibility | Meets requirements outlined in ISO 10993-1:2018 for externally communicating, prolonged exposure device indirectly contacting the blood path. Required tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Haemocompatibility) were performed. | Not specified, but generally a requirement for such devices. | Biocompatibility testing performed on the final Orchid Safety Release Valve™ demonstrates compliance. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of devices or cases) for each performance test. It only lists the types of tests performed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for the performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The listed tests are primarily engineering and laboratory-based performance evaluations, rather than studies requiring expert interpretation of diagnostic inputs or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests described are objective performance evaluations based on established international standards (ISO, ASTM, USP) and device specifications, not subjective assessments requiring adjudication by multiple experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical IV accessory, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers with AI assistance" are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a mechanical component and does not involve an algorithm. The performance evaluation is inherently "standalone" in the sense that it assesses the device's functional characteristics directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests is derived from:
- Engineering specifications and design requirements: For parameters like separation force.
- International standards (ISO, ASTM, USP): These standards define acceptable methodologies and thresholds for various tests (e.g., tensile strength, air/water leakage, sterilization, biocompatibility).
- Functional objectives: The device must reliably separate and close flow paths under specific tension.
8. The sample size for the training set
Not applicable. This device is a mechanical component, not a machine learning model, so there is no concept of a "training set" in the context of its development or validation.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 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
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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
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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 ClarkPresident |
| Address: | 5333 Wisteria Drive OklahomaCity, 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 CzamanskiProject Engineer, Regulatory Consultant |
| Address: | 2790 Mosside Blvd #800Monroeville, 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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| 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.
| ProductFeatures | SubjectLinear Health Sciences'Orchid Safety ReleaseValve™(K212064) | PredicateSite Saver, Inc./ LineusMedicalSafeBreak Vascular(DEN190043) | SubstantialEquivalenceDetermination |
|---|---|---|---|
| Classification | Class II | -same- | |
| Product Code | QOI | -same- | |
| RegulationNumber | 21 CFR §880.5220 | -same- | |
| DeviceClassificationName | Intravenous CatheterForce-ActivatedSeparation Device | -same- | |
| Indications forUse | The Linear HealthSciences™ Orchid SafetyRelease Valve™ is atension-activatedaccessory for singlepatient use and placedbetween the existing IVadministration set and IVextension set connection.The Orchid SRV™ isintended for use withelectronic IV pumps inperipheral IV catheterapplications where tensionmay act on the IV tubing.The Orchid SRV™ isdesigned to allow flow toan IV catheter. Whenexcessive tension acts onthe line, the Orchid SRV™separates and closes theflow path in bothdirections. The OrchidSRV™ can be used duringintermittent infusion andcontinuous infusion.The Orchid SRV™ isintended to aid inreduction of peripheral IVmechanical complicationsrequiring IV replacement.The Orchid SRV™ is foruse with patients eighteen(18) years of age andolder. | SafeBreak® Vascular isintended to separatewhen excessive tensionis exerted across aperipheral IVadministration set. WhenSafeBreak® Vascularseparates, fluid flow isstopped from theinfusion pump and bloodflow is stopped from thepatient's IV catheter.SafeBreak® Vascular isintended to aid inreduction of peripheralIV mechanicalcomplications requiringIV replacement.SafeBreak® Vascular isintended to be used onperipheral IV cathetersin adults and adolescentpopulations eighteen(18) years of age andolder receivingintermittent orcontinuous infusionswith an electronic pump. | The subject andpredicate devicesare intended toreducedislodgementduring IV infusion.However, theOrchid SRV has alower separationforce, which allowsthe device topreventdislodgement whenusing securementmethods that havelower pull forces. |
| Table 5-1: General Technological Characteristics Comparison | |||
| ProductFeatures | SubjectLinear Health Sciences'Orchid Safety ReleaseValve™(K212064) | PredicateSite Saver, Inc./ LineusMedicalSafeBreak Vascular(DEN190043) | SubstantialEquivalenceDetermination |
| Environment ofUse | Hospital | -same- | |
| Provided Sterile | Yes | -same- | |
| Principle ofOperation | The Orchid SafetyRelease Valve™ has luerlock connections that willlock the device in placeduring use. The femaleluer connects to anadministration set whilethe male luer connects toa vascular access devicehub or extension set. Onceconnected the deviceallows for continuous flow.The Orchid SRV willseparate into the male andfemale subassemblies,upon a tension event,automatically closing theflow path, whilemaintaining sterility andpreventing fluid leakageform the device. | The SafeBreak Vascularconnects to theneedleless connectorfound in the existing IVextension set and to theexisting IVadministration set vialuer connectors. Uponinstallation of theSafeBreak Vascular,infusion can occur. Upontension the SafeBreakVascular separates andthe valve on each end ofthe device closes,stopping flow. | The principle ofoperation for thesubject andpredicate devices isthe same. |
| User Profile | Physician or clinicalpersonnel with clearanceto administer IV sets andrelated products | -same- | |
| SeparationForce | 1-4.2 lbf | 4 ± 1 lbf | The lower limit of theOrchid SafetyRelease Valve'sseparation force of 1-4.2 lbf wasspecifically designedto provide subjectdevice separationprior to securementdevice failure even forthose securementdevices that come inat the lower end ofthe pull forcespectrum. Somemedical adhesivesare specificallyformulated to requirea lower pull force dueto the usage onelderly, fragile skin, or |
| those at risk ofincreased IVdislodgement. TheOrchid SRV's usespecifications thatwork across the lowend of the rangeprovide benefit tothese patients.Performancetesting performedto demonstratethat deviceconforms tospecification. | |||
| Vascular accessCatheter Type | Peripheral catheter | -same- | |
| For Use withElectronicPump | Yes | -same- | |
| Single Use | Yes | -same- | |
| Continuous andIntermittentInfusion | 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.
| ProductFeatures | SubjectLinear Health Sciences'Orchid Safety ReleaseValve™(K212064) | PredicateSite Saver, Inc./ LineusMedicalSafeBreak Vascular(DEN190043) | SubstantialEquivalenceDetermination |
|---|---|---|---|
| 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 <788>)
- 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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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.
§ 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.