(249 days)
No
The device description and performance studies focus on mechanical components and physical performance, with no mention of AI/ML terms or data processing.
Yes
The device is intended for "temporary occlusion of large vessels including patients requiring emergency control of hemorrhage," which is a direct medical intervention to treat a physiological condition, qualifying it as therapeutic.
No
The device is described as an "occlusion device" intended for "temporary occlusion of large vessels" to control hemorrhage, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components such as a sheath introducer kit, syringe, guidewire, balloon, hub, stopcock, suture tabs, and a J-tip straightener. These are hardware components, not software.
Based on the provided information, the COBRA-OS™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "temporary occlusion of large vessels including patients requiring emergency control of hemorrhage." This describes a direct intervention on the patient's circulatory system, not a test performed on samples taken from the body.
- Device Description: The description details a physical device designed to be inserted into a blood vessel and inflated to block blood flow. This is a therapeutic or interventional device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
In summary, the COBRA-OS™ is a medical device used for a therapeutic purpose (controlling hemorrhage by occluding vessels), not for diagnosing a condition by testing samples.
N/A
Intended Use / Indications for Use
The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Product codes
MJN
Device Description
The COBRA-OS™ is a large vessel occlusion device and includes a 4 French Custom Sheath Introducer Kit and a 10 cc syringe.
The occlusion device consists of a stiff inner guidewire with an atraumatic floppy distal J-tip that is housed in a compliant occlusion balloon with proximal and distal necks. The inner guidewire provides adequate stiffness. No other guidewires are required. The proximal neck of the balloon is connected to an overmolded hub and stopcock for balloon inflation and deflation. Suture tabs on the overmolded hub are used to secure the device to the patient's skin with sutures. A J-tip straightener is included and preloaded on the distal neck to facilitate the introduction of the device into the 4 French introducer sheath hemostasis valve. Pad printing marks on the outer occlusion device shaft indicate distance to the desired location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance bench and in vivo (animal) testing were performed to support the substantial equivalence of COBRA-OS to the identified predicate.
Performance Data (non-clinical):
- Dimensional
- Balloon Inflation/Deflation
- Balloon Diameter to Inflation Volume
- Balloon Burst
- Maximum Inflation Volume
- Tensile Strength
- Fatigue
- Torque
- Kink Radius
- Freedom From Leakage
- Occlusion Time
- Human Factors/Usability
- Sterilization
- Packaging
- Shelf Life
- Biocompatibility
Performance Testing (animal):
Performance testing was also conducted in vivo (swine model). The COBRA-OS™ meets applicable design and performance requirements.
Key Metrics
Not Found
Predicate Device(s)
ER-REBOA™, K170411
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
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February 22, 2021
Front Line Medical Technologies, Inc. % Sharon Iverson Quality and Regulatory Director Covance, Inc. 5353 Wayzata Blvd. Suite 505 Minneapolis, Minnesota 55416
Re: K201652
Trade/Device Name: COBRA-OS Kit, Accessory 4Fr Custom Introducer Sheath Kit, Accessory 10cc Syringe, COBRA-OS occlusion device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: January 15, 2021 Received: January 19, 2021
Dear Sharon Iverson:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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).
Sincerely,
for Carmen Gacchina Johnson, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201652
Device Name COBRA-OSTM
Indications for Use (Describe)
The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
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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TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Front Line Medical Technologies Inc.
609 Wellington St.,
London, Ontario, N6A3R6
Canada |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Asha Parekh
CEO
Front Line Medical Technologies Inc.
609 Wellington St.
London, Ontario, N6A3R6
Canada
Telephone (519) 777-1577
Email asha@frontlinemedtech.com |
| Date of Summary: | 15 JUN 2020 |
| Trade or Proprietary
Name: | COBRA-OSTM
Kit Reference Number F01K1 |
| Common or Usual Name: | Catheter, Intravascular Occluding, Temporary |
| Classification Name: | Vascular Clamp |
| Regulation Number | 21 CFR 870.4450 |
| Classification: | Class II |
| Product Code: | MJN |
| Review Panel: | Cardiovascular |
| Predicate Device: | ER-REBOA™, K170411 |
4
- Device Description: The COBRA-OS™ is a large vessel occlusion device and includes a 4 French Custom Sheath Introducer Kit and a 10 cc syringe.
The occlusion device consists of a stiff inner guidewire with an atraumatic floppy distal J-tip that is housed in a compliant occlusion balloon with proximal and distal necks. The inner guidewire provides adequate stiffness. No other guidewires are required. The proximal neck of the balloon is connected to an overmolded hub and stopcock for balloon inflation and deflation. Suture tabs on the overmolded hub are used to secure the device to the patient's skin with sutures. A J-tip straightener is included and preloaded on the distal neck to facilitate the introduction of the device into the 4 French introducer sheath hemostasis valve. Pad printing marks on the outer occlusion device shaft indicate distance to the desired location.
| Intended Use: | The COBRA-OSTM is intended for temporary occlusion of
large vessels. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The COBRA-OSTM is intended for temporary occlusion of
large vessels including patients requiring emergency control
of hemorrhage. |
Technological Characteristics:
The subject device has the same intended use, principles of operation, and basic technological characteristics for obtaining occlusion of the vessel.
The COBRA-OSTM has the following main differences from the predicate device:
- Compatible with 4 Fr introducer sheath
- . 64.9 cm effective length
- Includes accessories (4 Fr Custom Sheath Introducer Kit and 10 cc syringe) ●
- Atraumatic distal J-Tip
- Does not monitor blood pressure ●
The following performance bench and in vivo (animal) testing were performed to support the substantial equivalence of COBRA-OS to the identified predicate.
Performance Data (non-clinical):
- Dimensional
- Balloon Inflation/Deflation ●
- Balloon Diameter to Inflation Volume
- Balloon Burst ●
- Maximum Inflation Volume ●
5
- Tensile Strength
- . Fatigue
- . Torque
- Kink Radius ●
- Freedom From Leakage
- Occlusion Time
- . Human Factors/Usability
- Sterilization
- Packaging ●
- Shelf Life
- Biocompatibility ●
Performance Testing (animal):
Performance testing was also conducted in vivo (swine model). The COBRA-OS™ meets applicable design and performance requirements.
Substantial Equivalence Conclusion:
Based on the intended use, principles of operation, basic technological characteristics for obtaining occlusion of the vessel, and performance testing, the COBRA-OS™ is found substantially equivalent to the legally marketed predicate device.