(112 days)
Not Found
No
The device description and performance studies indicate a purely mechanical device with no software or electrical components, and there are no mentions of AI or ML in the summary.
No.
The primary purpose of this device is to protect the IV line from accidental dislodgement and reduce mechanical complications, not to treat a specific medical condition or disease.
No
The device is an accessory for IV administration sets designed to prevent IV mechanical complications by separating and closing flow paths when excessive tension occurs. It does not diagnose any condition or disease.
No
The device description and performance studies explicitly state that the device does not contain software and is a physical accessory for IV administration sets.
Based on the provided information, the Linear Health Sciences™ Orchid Safety Release Valve™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes a device that is placed between existing IV administration sets and extension sets to manage tension and prevent mechanical complications. It is a physical accessory for the IV delivery system.
- Device Description: The description details a mechanical device that separates under tension to close flow paths. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic or other health-related information. The Orchid SRV™ is a mechanical safety device for the IV tubing itself, not a diagnostic tool.
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 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.
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: Additional hemocompatibility tests were conducted per ISO 10993-4: 2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood: Partial Thromboplastin Time (PTT), Complement Activation, Platelet and Leukocyte Count (PLC) assay, and mechanical hemolysis.
Electrical Safety and Electromagnetic Compatibility (EMC): Not required as the device does not contain electrical or metal components.
Software Verification and Validation Testing: Not required as the device does not contain software.
Performance Testing - Animal: Not included, as it was determined no such testing was required to demonstrate substantial equivalence.
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.
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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.
September 6, 2024
Linear Health Sciences LLC Jessica Czamanski Director of Product and Regulatory Affairs 840 Research Parkway Ste 250 Oklahoma City, Oklahoma 73104
Re: K241415
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: August 9, 2024 Received: August 9, 2024
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"
1
(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).
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 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. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors
2
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241415
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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K241415 - 510(k) SUMMARY
This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.
Submitter l.
| Submitter's Name: | Linear Health Sciences, LLC |
|---|---|
| Contact Person: | Mr. Daniel Clark |
| CEO | |
| Address: | 840 Research Parkway, STE 250 |
| Oklahoma City, OK 73104 | |
| Telephone: | (310) 721-6222 |
| Email: | dan.clark@linearsciences.com |
| Date Preparation: | September 6, 2024 |
II. Application Correspondent
| Contact's Name: | Linear Health Sciences, LLC |
|---|---|
| Contact Person: | Jessica Czamanski |
| Director of Product and Regulatory Affairs | |
| Address: | 840 Research Parkway, STE 250 |
| Oklahoma City, OK 73104 | |
| Telephone: | (754) 422-9101 |
| Email: | jessica.czamanski@linearsciences.com |
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 ValveTM |
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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 the "I" stylized as a vertical line with two small squares on either side. Below "LINEAR" in a smaller, light gray font are the words "HEALTH SCIENCES". The TM symbol is in the upper right corner of the word "LINEAR".
| 510(k) Number: | K232094 |
|---|---|
| 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 contraindications to allow for use with blood.
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 written in a large, blue, sans-serif font. The letters are spaced closely together, and the "I" in "LINEAR" is stylized to look like two vertical lines. The letters "TM" are written in a small, superscript font in the upper right corner of the word "LINEAR". Below the word "LINEAR", the words "HEALTH SCIENCES" are written in a smaller, gray, sans-serif font.
| Table 1: General Technological Characteristics Comparison | |||
|---|---|---|---|
| Product Features | Proposed | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| Valve™ | |||
| (K241415) | Predicate | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| Valve™ | |||
| (K232094) | Substantial | ||
| Equivalence | |||
| Determination | |||
| Classification | Class II | Class II | Same |
| Product Code | QOI | QOI | Same |
| Regulation | |||
| Number | §880.5220 | §880.5220 | Same |
| Device | |||
| Classification | |||
| Name | Intravenous Catheter | ||
| Force-Activated | |||
| Separation Device | 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 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. | 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. | 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 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 | 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 | Same | ||
| Table 1: General Technological Characteristics Comparison | |||
| Product Features | Proposed | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| ValveTM | |||
| (K241415) | Predicate | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| ValveTM | |||
| (K232094) | Substantial | ||
| Equivalence | |||
| Determination | |||
| Contraindications | flow path in both | ||
| directions. The Orchid | |||
| SRVTM can be used | |||
| during intermittent | |||
| infusion and continuous | |||
| infusion. | |||
| The Orchid SRVTM 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 SRVTM should | |||
| not be used for any type | |||
| of fluid administration | |||
| other than intravenous. | |||
| Not for use with feeding | |||
| tubes, drains, or other | |||
| tubing applications | |||
| outside of intravenous | |||
| applications. Not for use | |||
| in withdrawing blood or | |||
| fluids. Not for intra-arterial | |||
| use. Not for use with | |||
| power injection systems | |||
| or high-pressure infusion | |||
| systems. Not for use with | |||
| umbilical vessel catheters. | |||
| Not for use under 2 weeks | |||
| of age. Not for use in line | |||
| during the transfusion of | |||
| biologics. | flow path in both | ||
| directions. The Orchid | |||
| SRVTM can be used | |||
| during intermittent | |||
| infusion and continuous | |||
| infusion. | |||
| The Orchid SRVTM 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 SRVTM should | |||
| not be used for any type | |||
| of fluid administration | |||
| other than intravenous. | |||
| Not for use with feeding | |||
| tubes, drains, or other | |||
| tubing applications | |||
| outside of intravenous | |||
| applications. Not for use | |||
| in withdrawing blood or | |||
| fluids. Not for intra-arterial | |||
| use. Not for use with | |||
| power injection systems | |||
| or high-pressure infusion | |||
| systems. Not for use with | |||
| umbilical vessel | |||
| catheters. Not for use | |||
| under 2 weeks of age. | |||
| Not for use in line during | |||
| the transfusion of blood, | |||
| blood products, or | |||
| biologics. | Contraindications have | ||
| been updated to | |||
| remove "blood, blood | |||
| products, or" from the | |||
| contraindication | |||
| statements. Blood and | |||
| blood product use is | |||
| supported by | |||
| additional | |||
| hemocompatibility | |||
| testing performed on | |||
| the subject device | |||
| (refer to Section X | |||
| below). | |||
| Materials | Polycarbonate and | ||
| silicone | Polycarbonate and | ||
| silicone | Same | ||
| Environment of | |||
| Use | Hospital | Hospital | Same |
| Provided Sterile | Yes | Yes | Same |
| Principle of | |||
| Operation | The Orchid Safety | ||
| Release ValveTM has luer | |||
| lock connections that will | |||
| lock the device in place | |||
| during use. The female | |||
| luer connects to an | |||
| administration set while | The Orchid Safety | ||
| Release ValveTM has luer | |||
| lock connections that will | |||
| lock the device in place | |||
| during use. The female | |||
| luer connects to an | |||
| administration set while | Same | ||
| Table 1: General Technological Characteristics Comparison | |||
| Product Features | Proposed | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| ValveTM | |||
| (K241415) | Predicate | ||
| Linear Health Sciences' | |||
| Orchid Safety Release | |||
| ValveTM | |||
| (K232094) | Substantial | ||
| Equivalence | |||
| Determination | |||
| the male luer connects to | |||
| a vascular access device | |||
| hub or extension set. | |||
| Once connected the | |||
| device allows for | |||
| continuous flow. The | |||
| Orchid SRV will separate | |||
| into the male and female | |||
| subassemblies, upon a | |||
| tension event, | |||
| automatically closing the | |||
| flow path, while | |||
| maintaining sterility and | |||
| preventing fluid leakage | |||
| form the device. | the 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. | |||
| User Profile | Physician or clinical | ||
| personnel with clearance | |||
| to administer IV sets and | |||
| related products | Physician or clinical | ||
| personnel with clearance | |||
| to administer IV sets and | |||
| related products | Same | ||
| Separation Force | 1-4.2 lbf | 1-4.2 lbf | Same |
| Vascular Access | |||
| Catheter Type | Peripheral and Central IV | ||
| Catheters | Peripheral and Central IV | ||
| Catheters | Same | ||
| For Use with | |||
| Electronic Pumps | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Continuous and | |||
| Intermittent | |||
| 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 written in large, blue, sans-serif font. Below the word "LINEAR" is the phrase "HEALTH SCIENCES" in a smaller, gray, sans-serif font. The letters are spaced out more than the word "LINEAR".
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ﮧ :
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.
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Image /page/9/Picture/0 description: The image shows the logo for Linear Health Sciences. The word "LINEAR" is in blue, with a small "TM" symbol in the upper right corner. Below "LINEAR" is the phrase "HEALTH SCIENCES" in gray. The logo is simple and modern, with a focus on the company's name.
Biocompatibility
To demonstrate the device's safe use with blood products, the following additional hemocompatibility tests were conducted per ISO 10993-4: 2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood: Partial Thromboplastin Time (PTT), Complement Activation, Platelet and Leukocyte Count (PLC) assay, and mechanical hemolysis.
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. Justification of the latter has been included in this submission to support the MR Safe symbol to the device labeling.
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.
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. Additional testing performed to support limited blood contact did not raise new questions for safety or effectiveness. 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 K232094.