(93 days)
Not Found
No
The device description and performance studies explicitly state that the device does not contain software and is a purely mechanical, tension-activated valve. There is no mention of AI or ML.
No
The device is described as an accessory for an IV administration set, intended to aid in the reduction of peripheral IV mechanical complications requiring IV replacement. It does not treat or cure a disease or condition.
No
The device is described as an accessory for IV administration sets designed to stop fluid flow when excessive tension is applied, not to diagnose a condition.
No
The device description and performance studies explicitly state that the device is a physical accessory that connects to existing IV sets and does not contain software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory for IV administration sets and extensions, designed to prevent complications related to tension on the IV tubing. It is used in conjunction with IV therapy, not to diagnose a condition or analyze a sample from the body.
- Device Description: The description details a mechanical device that separates under tension to stop fluid flow. This is a physical function related to the delivery of fluids, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the Orchid Safety Release Valve™ is a medical device used in the delivery of IV fluids, not an in vitro diagnostic device.
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 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 two (2) weeks 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, 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
two (2) weeks 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)
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.
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: Pediatric extrapolation results supported safety and effectiveness of the Orchid SRV in pediatric patients.
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 shows 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 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.
May 4, 2023
Linear Health Sciences, LLC % Jessica Czamanski Managing Director MedTactics, LLC 19924 NE 19th PL Miami, Florida 33179
Re: K230266
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: January 20, 2023 Received: January 31, 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 (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
1
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 (OS) 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 Walloschek
David Wolloscheck, Ph.D. Acting 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) K230266
Device Name Orchid Safety Release Valve™
Indications for Use (Describe)
The Linear Health Science™ Orchid Safety Release Valve™ is a tension-activated accessory for single patient use and placed between the existing IV administration set and IV extension. 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 SRVTM 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 SRVTM is for use with patients two (2) weeks 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 word "LINEAR" is in large, blue, sans-serif font, with a small "TM" symbol in the upper right corner. Below the word "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray, sans-serif font. A thin gray line extends from the left of the word "LINEAR" to the right.
K230266 - 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 |
| CEO | |
| Address: | 5333 Wisteria Drive |
| Oklahoma City, OK 73142 | |
| Telephone: | (310) 721-6222 |
| Email: | dan.clark@linearsciences.com |
| Date Preparation: | May 4, 2023 |
II. Application Correspondent
| Contact's Name: | MedTactics, LLC |
|---|---|
| Contact Person: | Jessica Czamanski |
| Managing Director | |
| Address: | 19924 NE 19TH PL |
| Miami, FL 33179 | |
| Telephone: | (754) 422-9101 |
| Email: | iczamanski@medtactics.us |
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/4/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in blue, with a vertical line in the middle of the first letter. The words "HEALTH SCIENCES" are in gray below the word "LINEAR". There is a horizontal line on either side of the words "HEALTH SCIENCES".
| 510(k) Number: | K212064 |
|---|---|
| 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 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 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 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 auide.
The following table (Table 5-1) provides an overview of general technological characteristics in comparison to the predicate device.
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Image /page/5/Picture/0 description: The image contains the logo for Linear Health Sciences. Below the logo is the text 'HEALTH SCIENCES' in a smaller font size. The image also contains the text 'Table 5-1: General Technological Characteristics Comparison'.
| Table 5-1: General Technological Characteristics Comparison | |||
|---|---|---|---|
| Product Features | Proposed | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| Valve™ | Predicate | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| Valve™ | |||
| (K212064) | Substantial | ||
| Equivalence | |||
| Determination | |||
| Classification | Class II | -same- | |
| Product Code | QOI | -same- | |
| Regulation | |||
| Number | §880.5220 | -same- | |
| Device | |||
| Classification | |||
| Name | Intravenous Catheter | ||
| Force-Activated | |||
| Separation Device | -same- | ||
| 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. | -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 | 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 | Indications for use are | ||
| being updated to | |||
| include pediatric | |||
| patients 2 weeks old to | |||
| 17 years old. The | |||
| device performance of | |||
| the subject and | |||
| predicate device are | |||
| identical and | |||
| compatible with IV | |||
| therapy in adult and | |||
| pediatric patients. The | |||
| results of pediatric | |||
| extrapolation | |||
| supported the | |||
| similarities in risk | |||
| profiles across all | |||
| patient populations. | |||
| Therefore, the change | |||
| in indication does not | |||
| Table 5-1: General Technological Characteristics Comparison | |||
| Proposed | |||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| Valve™ | Predicate | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| Valve™ | |||
| (K212064) | Substantial | ||
| Equivalence | |||
| Determination | |||
| Product Features | 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 two (2)
weeks of age and older. | 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. | questions of safety or
effectiveness. |
| Materials | Polycarbonate and
silicone | -same- | |
| 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. | -same- | |
| User Profile | Physician or clinical
personnel with clearance
to administer IV sets and
related products | -same- | |
| Separation Force | 1-4.2 lbf | -same- | |
| Product Features | Proposed
Linear Health Sciences'
Orchid Safety Release
Valve™ | Predicate
Linear Health Sciences'
Orchid Safety Release
Valve™
(K212064) | Substantial
Equivalence
Determination |
| Vascular Access
Catheter Type | Peripheral IV Catheters | -same- | |
| For Use with
Electronic Pumps | Yes | -same- | |
| Single Use | Yes | -same- | |
| Continuous and
Intermittent
Infusion | Yes | -same- | |
| Sterilization | Ethylene Oxide | -same- | |
| SAL | 10-6 | -same- | |
| Shelf-Life | 2 years | -same- | |
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Image /page/6/Picture/0 description: The image shows the logo for Linear Health Sciences. The logo is blue and has the words "LINEAR" and "HEALTH SCIENCES" on it. Below the logo is the text "Table 5-1: General Technological Characteristics Comparison".
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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, with a horizontal line extending from the left side of the "L" and a trademark symbol next to the "R". Below "LINEAR" in a smaller, gray, sans-serif font are the words "HEALTH SCIENCES."
echnological Characteristics Comparison
IX. 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.
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
Pediatric extrapolation results supported safety and effectiveness of the Orchid SRV in pediatric patients.
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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 thin horizontal line extending from the left side of the "L" and the right side of the "R". The words "HEALTH SCIENCES" are in gray below the word "LINEAR".
X. 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 pediatric extrapolation assessment demonstrates that the differences in the indications for use do not raise any new or different questions of safety or efficacy. The information provided in this submission demonstrates that the device is substantially equivalent to its predicate.