(82 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 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.
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.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting raw performance data or detailed study methodologies.
Here's a breakdown of why I cannot fulfill your request based on this document:
- Acceptance Criteria and Reported Device Performance: While the document implies certain performance characteristics (e.g., separating when excessive tension applies, closing flow path), it does not provide a table of explicit acceptance criteria or quantitative performance metrics from a study for the subject device. It states, "There is no change in performance data since there are no changes to the device or its manufacturing processes," referring back to the predicate device.
- Sample Size and Data Provenance (Test Set): No information on a test set sample size, country of origin, or whether data was retrospective or prospective is present.
- Number of Experts and Qualifications (Ground Truth for Test Set): The document does not describe the establishment of ground truth for any test set, nor does it mention experts or their qualifications.
- Adjudication Method: No adjudication method is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document does not mention an MRMC study or any comparison of human reader performance with or without AI assistance, as the device is a mechanical one, not an AI-powered diagnostic tool.
- Standalone Performance Study: No standalone performance study details are provided.
- Type of Ground Truth Used: Not applicable for a mechanical device in this context, as there's no diagnostic component.
- Sample Size for Training Set: Not applicable as this is a mechanical device, not a machine learning model.
- Ground Truth for Training Set: Not applicable.
What the document does state regarding performance:
The document relies on the equivalence to its predicate device (K230266) and an "extrapolation and benefit/risk assessment" to support the expanded indications for use. It explicitly says:
- "There is no change in performance data since there are no changes to the device or its manufacturing processes." (Page 9)
- "Extrapolation results supported safety and effectiveness of the Orchid SRV in all IVs." (Page 9)
- "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." (Page 9)
In essence, this FDA summary asserts that because the device is fundamentally identical to its previously cleared predicate, its performance (and the studies supporting that performance) also remain unchanged. The new submission is primarily to expand the "Indications for Use" from "peripheral IV catheters" to "all IV catheters" based on an extrapolation assessment rather than new, large-scale clinical performance studies directly included in this specific 510(k) summary.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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 ClarkCEO |
| Address: | 5333 Wisteria DriveOklahoma City, OK 73142 |
| Telephone: | (310) 721-6222 |
| Email: | dan.clark@linearsciences.com |
| Date Preparation: | October 3, 2023 |
II. Application Correspondent
| Contact's Name: | Linear Health Sciences, LLC |
|---|---|
| Contact Person: | Jessica CzamanskiDirector of Product and Regulatory Affairs |
| Address: | 5333 Wisteria DriveOklahoma City, OK 73142 |
| Telephone: | (754) 422-9101 |
| Email: | jczamanski@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/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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| Table 1: General Technological Characteristics Comparison | |||
|---|---|---|---|
| Product Features | ProposedLinear Health Sciences'Orchid Safety ReleaseValve™(K232094) | PredicateLinear Health Sciences'Orchid Safety ReleaseValve™(K230266) | SubstantialEquivalenceDetermination |
| Classification | Class II | Class II | Same |
| Product Code | QOI | QOI | Same |
| RegulationNumber | §880.5220 | §880.5220 | Same |
| DeviceClassificationName | Intravenous CatheterForce-ActivatedSeparation Device | Intravenous CatheterForce-ActivatedSeparation Device | Same |
| Intended Use | The Linear HealthSciences™ Orchid SafetyRelease Valve™ is atension-activatedaccessory, providedsterile and for single use,in line with an IVadministration set and IVextension set on a patient.The Orchid SRV™provides a quickseparation feature thatallows the device toquickly separate into twohalves upon tension,closing the flow path toprevent leakage. Thedevice is intended toreduce the risk of IVcatheter failure, requiringIV catheter replacement. | The Linear HealthSciences™ Orchid SafetyRelease Valve™ is atension-activatedaccessory, providedsterile and for single use,in line with an IVadministration set andperipheral IV extensionset on a patient. TheOrchid SRV™ provides aquick separation featurethat allows the device toquickly separate into twohalves upon tension,closing the flow path toprevent leakage. Thedevice is intended toreduce the risk of IVcatheter failure, requiringIV catheter replacement. | The intended use ofthe subject devicedoes not specifyperipheral use. Theintended use remainsas a tension-activatedaccessory for use in IVtherapy. According todata presented in thissubmission, using wellestablished methods,this labeling changedoes not change therisk profile of thedevice. |
| Indications for Use | 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 in IVcatheter applicationswhere tension may act onthe IV tubing. The OrchidSRV™ is designed toallow flow to an IVcatheter. When excessivetension acts on the line,the Orchid SRV™ | 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 wheretension may act on the IVtubing. The OrchidSRV™ is designed toallow flow to an IVcatheter. When excessivetension acts on the line,the Orchid SRV™ | Indications for use arebeing updated toremove the word"peripheral" to allowuse of the Orchid SRVwith all IVs. Accordingto data presented inthis submission, usingwell establishedmethods,extrapolationassessment,benefit/riskassessment, andliterature, this labelingchange does notchange the risk profileof the device. |
| ProposedLinear Health Sciences'Orchid Safety ReleaseValve™(K232094) | PredicateLinear Health Sciences'Orchid Safety ReleaseValve™(K230266) | SubstantialEquivalenceDetermination | |
| Product Features | flow path in bothdirections. The OrchidSRV™ can be usedduring intermittentinfusion and continuousinfusion.The Orchid SRV™ isintended to aid inreduction of IVmechanical complicationsrequiring IV replacement.The Orchid SRV™ is foruse with patients two (2)weeks of age and older. | separates and closes theflow path in bothdirections. The OrchidSRV™ can be usedduring intermittentinfusion and continuousinfusion.The Orchid SRV™ isintended to aid inreduction of peripheral IVmechanical complicationsrequiring IV replacement.The Orchid SRV™ is foruse with patients two (2)weeks of age and older. | |
| Materials | Polycarbonate andsilicone | Polycarbonate andsilicone | Same |
| Environment ofUse | Hospital | Hospital | Same |
| Provided Sterile | Yes | 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.Once connected thedevice allows forcontinuous flow. TheOrchid SRV will separateinto the male and femalesubassemblies, upon atension event,automatically closing theflow path, whilemaintaining sterility andpreventing fluid leakageform the device. | 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.Once connected thedevice allows forcontinuous flow. TheOrchid SRV will separateinto the male and femalesubassemblies, upon atension event,automatically closing theflow path, whilemaintaining sterility andpreventing fluid leakageform the device. | Same |
| User Profile | Physician or clinicalpersonnel with clearanceto administer IV sets andrelated products | Physician or clinicalpersonnel with clearanceto administer IV sets andrelated products | Same |
| Table 1: General Technological Characteristics Comparison | |||
| Product Features | ProposedLinear Health Sciences'Orchid Safety ReleaseValve™(K232094) | PredicateLinear Health Sciences'Orchid Safety ReleaseValve™(K230266) | SubstantialEquivalenceDetermination |
| Vascular AccessCatheter Type | Peripheral and Central IVCatheters | Peripheral IV Catheters | Indications for use arebeing updated toremove the word"peripheral" to allowuse of the Orchid SRVwith all IV catheters.According to datapresented in thissubmission, using wellestablished methods,extrapolationassessment,benefit/riskassessment, andliterature, this labelingchange does notchange the risk profileof the device. |
| For Use withElectronic Pumps | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Continuous andIntermittentInfusion | 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/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.
§ 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.