Orchid Safety Release ValveTM

K232094 · Linear Health Sciences, LLC · QOI · Oct 3, 2023 · General Hospital

Device Facts

• Record ID: K232094
• Device Name: Orchid Safety Release ValveTM
• Applicant: Linear Health Sciences, LLC
• Product Code: QOI · General Hospital
• Decision Date: Oct 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5220
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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 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.

Device Story

Orchid Safety Release Valve (SRV) is a sterile, single-use, tension-activated accessory for IV therapy; placed between IV administration set and extension set. Device features luer-lock connections; allows continuous flow during normal operation. Upon excessive longitudinal tension, device separates into two halves; automatically closes flow path in both directions to prevent leakage and maintain sterility. Used in hospital settings by clinicians; compatible with electronic IV pumps. Intended to reduce IV catheter failure and mechanical complications requiring replacement. No software or electrical components; purely mechanical operation.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by extrapolation assessment and benefit/risk analysis regarding the expansion of indications to include central IV catheters.

Technological Characteristics

Materials: Polycarbonate and silicone. Principle: Mechanical tension-activated separation with luer-lock connections. Form factor: In-line IV accessory. Sterilization: Ethylene Oxide (SAL 10^-6). Shelf-life: 2 years. No electrical or software components.

Indications for Use

Indicated for patients 2 weeks of age and older. Tension-activated accessory placed between IV administration set and IV extension set. Intended for use with electronic IV pumps in IV catheter applications (peripheral and central) where tension may act on tubing. Designed to separate and close flow path in both directions during excessive tension. Used during intermittent and continuous infusion to aid in reduction of IV mechanical complications requiring IV replacement.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, intravenous catheter force-activated separation device is subject to the following special controls:

*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.

Predicate Devices

• Orchid Safety Release Valve™ (K230266)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 3, 2023

Linear Health Sciences LLC Jessica Czamanski Director of Product and Regulatory Affairs 5333 Wisteria Drive Oklahoma City, Oklahoma 73142

## Re: K232094

Trade/Device Name: Orchid Safety Release Valve™M Regulation Number: 21 CFR 880.5220 Regulation Name: Intravenous Catheter Force-Activated Separation Device Regulatory Class: Class II Product Code: QOI Dated: August 4, 2023 Received: August 4, 2023

## 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. 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) K232094

Device Name Orchid Safety Release Valve™

#### 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 SRV™ is intended for use with electronic IV pumps in 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 IV mechanical complications requiring IV replacement.

The Orchid SRVTM is for use with patients two (2) weeks of age and older.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="10" width="10"> <rect height="10" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

| X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in blue, with the "I" in "LINEAR" being stylized as a vertical line with a small circle on top. Below "LINEAR" is the text "HEALTH SCIENCES" in gray. The TM symbol is in the upper right corner of the word "LINEAR".

## K232094 - 510(k) SUMMARY

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.

#### l. Submitter

| Submitter's Name: | Linear Health Sciences, LLC |
|-------------------|------------------------------------------------|
| Contact Person: | Mr. Daniel Clark<br>CEO |
| Address: | 5333 Wisteria Drive<br>Oklahoma City, OK 73142 |
| Telephone: | [phone] |
| Email: | [e-mail] |
| Date Preparation: | October 3, 2023 |

## II. Application Correspondent

| Contact's Name: | Linear Health Sciences, LLC |
|-----------------|-----------------------------------------------------------------|
| Contact Person: | Jessica Czamanski<br>Director of Product and Regulatory Affairs |
| Address: | 5333 Wisteria Drive<br>Oklahoma City, OK 73142 |
| Telephone: | [phone] |
| Email: | [e-mail] |

## III. 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

| Manufacturer: | Linear Health Sciences, LLC |
|---------------|------------------------------|
| Device Name: | Orchid Safety Release Valve™ |

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Image /page/5/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue font, with a small trademark symbol in the upper right corner. Below "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray font. The logo is simple and modern, with a focus on the company's name and area of expertise.

| 510(k) Number: | K230266 |
|-------------------------|-------------------|
| 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, 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 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 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 IV mechanical complications requiring IV replacement. The Orchid SRV™ is for use with patients two (2) weeks of age and older.

## VIII.Comparison of Technological Characteristics with the Predicate Devices

There are no differences in technological characteristics of the device. Only differences are present in the labeling of the Orchid Safety Release Valve, specifically the instructions for use and quick reference guide.

The following table (Table 1) provides an overview of general technological characteristics in comparison to the predicate device.

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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 trademark symbol in the upper right corner. Below the word "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray, sans-serif font.

| Table 1: General Technological Characteristics Comparison | | | |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Features | Proposed<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K232094) | Predicate<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K230266) | Substantial<br>Equivalence<br>Determination |
| Classification | Class II | Class II | Same |
| Product Code | QOI | QOI | Same |
| Regulation<br>Number | §880.5220 | §880.5220 | Same |
| Device<br>Classification<br>Name | Intravenous Catheter<br>Force-Activated<br>Separation Device | Intravenous Catheter<br>Force-Activated<br>Separation Device | Same |
| Intended Use | The Linear Health<br>Sciences™ Orchid Safety<br>Release Valve™ is a<br>tension-activated<br>accessory, provided<br>sterile and for single use,<br>in line with an IV<br>administration set and IV<br>extension set on a patient.<br>The Orchid SRV™<br>provides a quick<br>separation feature that<br>allows the device to<br>quickly separate into two<br>halves upon tension,<br>closing the flow path to<br>prevent leakage. The<br>device is intended to<br>reduce the risk of IV<br>catheter failure, requiring<br>IV catheter replacement. | The Linear Health<br>Sciences™ Orchid Safety<br>Release Valve™ is a<br>tension-activated<br>accessory, provided<br>sterile and for single use,<br>in line with an IV<br>administration set and<br>peripheral IV extension<br>set on a patient. The<br>Orchid SRV™ provides a<br>quick separation feature<br>that allows the device to<br>quickly separate into two<br>halves upon tension,<br>closing the flow path to<br>prevent leakage. The<br>device is intended to<br>reduce the risk of IV<br>catheter failure, requiring<br>IV catheter replacement. | The intended use of<br>the subject device<br>does not specify<br>peripheral use. The<br>intended use remains<br>as a tension-activated<br>accessory for use in IV<br>therapy. According to<br>data presented in this<br>submission, using well<br>established methods,<br>this labeling change<br>does not change the<br>risk profile of the<br>device. |
| Indications for Use | The Linear Health<br>Sciences™ Orchid Safety<br>Release Valve™ is a<br>tension-activated<br>accessory for single<br>patient use and placed<br>between the existing IV<br>administration set and IV<br>extension set connection.<br>The Orchid SRV™ is<br>intended for use with<br>electronic IV pumps in IV<br>catheter applications<br>where tension may act on<br>the IV tubing. The Orchid<br>SRV™ is designed to<br>allow flow to an IV<br>catheter. When excessive<br>tension acts on the line,<br>the Orchid SRV™ | The Linear Health<br>Sciences™ Orchid Safety<br>Release Valve™ is a<br>tension-activated<br>accessory for single<br>patient use and placed<br>between the existing IV<br>administration set and IV<br>extension set connection.<br>The Orchid SRV™ is<br>intended for use with<br>electronic IV pumps in<br>peripheral IV catheter<br>applications where<br>tension may act on the IV<br>tubing. The Orchid<br>SRV™ is designed to<br>allow flow to an IV<br>catheter. When excessive<br>tension acts on the line,<br>the Orchid SRV™ | Indications for use are<br>being updated to<br>remove the word<br>"peripheral" to allow<br>use of the Orchid SRV<br>with all IVs. According<br>to data presented in<br>this submission, using<br>well established<br>methods,<br>extrapolation<br>assessment,<br>benefit/risk<br>assessment, and<br>literature, this labeling<br>change does not<br>change the risk profile<br>of the device. |
| | Proposed<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K232094) | Predicate<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K230266) | Substantial<br>Equivalence<br>Determination |
| Product Features | flow path in both<br>directions. The Orchid<br>SRV™ can be used<br>during intermittent<br>infusion and continuous<br>infusion.<br><br>The Orchid SRV™ is<br>intended to aid in<br>reduction of IV<br>mechanical complications<br>requiring IV replacement.<br><br>The Orchid SRV™ is for<br>use with patients two (2)<br>weeks of age and older. | separates and closes the<br>flow path in both<br>directions. The Orchid<br>SRV™ can be used<br>during intermittent<br>infusion and continuous<br>infusion.<br><br>The Orchid SRV™ is<br>intended to aid in<br>reduction of peripheral IV<br>mechanical complications<br>requiring IV replacement.<br><br>The Orchid SRV™ is for<br>use with patients two (2)<br>weeks of age and older. | |
| Materials | Polycarbonate and<br>silicone | Polycarbonate and<br>silicone | Same |
| Environment of<br>Use | Hospital | Hospital | Same |
| Provided Sterile | Yes | Yes | Same |
| Principle of<br>Operation | The Orchid Safety<br>Release Valve™ has luer<br>lock connections that will<br>lock the device in place<br>during use. The female<br>luer connects to an<br>administration set while<br>the male luer connects to<br>a vascular access device<br>hub or extension set.<br>Once connected the<br>device allows for<br>continuous flow. The<br>Orchid SRV will separate<br>into the male and female<br>subassemblies, upon a<br>tension event,<br>automatically closing the<br>flow path, while<br>maintaining sterility and<br>preventing fluid leakage<br>form the device. | The Orchid Safety<br>Release Valve™ has luer<br>lock connections that will<br>lock the device in place<br>during use. The female<br>luer connects to an<br>administration set while<br>the male luer connects to<br>a vascular access device<br>hub or extension set.<br>Once connected the<br>device allows for<br>continuous flow. The<br>Orchid SRV will separate<br>into the male and female<br>subassemblies, upon a<br>tension event,<br>automatically closing the<br>flow path, while<br>maintaining sterility and<br>preventing fluid leakage<br>form the device. | Same |
| User Profile | Physician or clinical<br>personnel with clearance<br>to administer IV sets and<br>related products | Physician or clinical<br>personnel with clearance<br>to administer IV sets and<br>related products | Same |
| Table 1: General Technological Characteristics Comparison | | | |
| Product Features | Proposed<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K232094) | Predicate<br>Linear Health Sciences'<br>Orchid Safety Release<br>Valve™<br>(K230266) | Substantial<br>Equivalence<br>Determination |
| Vascular Access<br>Catheter Type | Peripheral and Central IV<br>Catheters | Peripheral IV Catheters | Indications for use are<br>being updated to<br>remove the word<br>"peripheral" to allow<br>use of the Orchid SRV<br>with all IV catheters.<br>According to data<br>presented in this<br>submission, using well<br>established methods,<br>extrapolation<br>assessment,<br>benefit/risk<br>assessment, and<br>literature, this labeling<br>change does not<br>change the risk profile<br>of the device. |
| For Use with<br>Electronic Pumps | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Continuous and<br>Intermittent<br>Infusion | Yes | Yes | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| SAL | 10-6 | 10-6 | Same |
| Shelf-Life | 2 years | 2 years | Same |

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Image /page/7/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in large, blue, sans-serif font. Below that, in a smaller, gray, sans-serif font, are the words "HEALTH SCIENCES."

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Image /page/8/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in blue, with a small trademark symbol next to the "R". Below "LINEAR" is the phrase "HEALTH SCIENCES" in gray. The logo is simple and modern.

#### IX. Sterilization

There are no differences in the sterilization process between the subject and the predicate device.

#### X. Performance Data

The following performance data was considered in support of the substantial equivalence determination.

#### Performance Testing - Bench

There is no change in performance data since there are no changes to the device or its manufacturing processes.

#### Biocompatibility

There is no change in biocompatibility since there are no changes to the device or its manufacturing processes.

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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 font, with a small trademark symbol in the upper right corner. Below "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray font. The logo is simple and modern, with a focus on the company's name and area of expertise.

### Electrical Safety and Electromagnetic Compatibility (EMC)

There are no electrical or metal components in the proposed Orchid Safety Release Valve™, therefore, the proposed device does not require EMC and Electrical Safety evaluation.

#### Software Verification and Validation Testing

The Orchid Safety Release Valve™ does not contain software; therefore, the proposed device does not require software verification and validation testing.

#### Performance Testing - Animal

This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.

#### Clinical Data

Extrapolation results supported safety and effectiveness of the Orchid SRV in all IVs.

#### XI. Conclusion

The Orchid Safety Release Valve™ has the same intended use, environment, operating principle and fundamental technology, manufacturing, and materials as the predicate device. The conducted extrapolation and benefit/risk assessment demonstrate that the differences in the indications for use do not raise any new or different questions of safety and efficacy. The information provided in this submission demonstrates that the subject device, Orchid Safety Release Valve™ is substantially equivalent to its predicate, Orchid Safety Release Valve™ cleared under K230266.