GEM™ BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

Device Description

The GEM™ Biover Microvascular Clamps (Clamps) are arterial and venous clamps in both single and double clamp configurations, available in varying sizes. The clamps are sterile, disposable clamps for single use. The clamps are used in microsurgery, plastic surgery, and hand surgery for the temporary occlusion of blood vessels during an anastomosis.

The clamps are available for arteries and veins. The clamping force is higher for the arterial clamps than for the veinous clamps. The clamps are identified by a product reference code and by the color of the clamp. The clamps for veins are green, and the clamps for arteries are yellow.

The clamps are packaged individually in two Tyvek pouches (double pouched). The devices in the Tyvek pouches are gamma sterilized and are placed in cartons of 10. The clamps are used once and are disposed of after use.

AI/ML Overview

This document is a 510(k) summary for the GEM™ Biover Microvascular Clamps, asserting their substantial equivalence to a previously cleared predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in a robust statistical study.

Based on the provided text, the device is not an AI/ML powered device, nor is it a diagnostic device that requires high-level performance metrics, such as sensitivity, specificity, or AUC. The submission is for a physical medical device (microvascular clamps). Therefore, the information requested in the prompt regarding AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this document.

The document states:

"The GEM Biover microvascular clamps remain unchanged from the predicate device."
"There are no engineering or performance changes to the device or its packaging."

The "performance data" section mentions:

"The label design change and the outer carton sales unit design change were assessed and validated in a Packaging Summative Human Factors/Usability Study."
"Historical complaint data were reviewed and indicate no use-related concerns, thus, there are no use-related risks or complaints that trigger a need for further Human Factors validation."

This indicates that the "performance" considered for this submission relates to packaging and user interface (labeling/carton design), and the study conducted was a human factors/usability study, not a clinical performance study measuring accuracy or efficacy of a medical algorithm.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance, and ground truth for a diagnostic or AI-powered device, as these details are not present and are not relevant to this type of device submission.

Summary

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September 14, 2022

Synovis Micro Companies Alliance, Inc. (a subsidiary of Baxter International. Inc.) Julie Carlston Senior Manager, Regulatory Affairs 439 Industrial Lane Birmingham, Alabama 35211

Re: K221843

Trade/Device Name: GEM™ Biover Microvascular Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: DXC Dated: August 12, 2022 Received: August 15, 2022

Dear Julie Carlston:

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.

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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.

Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221843

Device Name GEMTM BIOVER Microvascular Clamps

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K221843

l. Submitter Synovis Micro Companies Alliance, Inc. A Subsidiary of Baxter International Inc. 439 Industrial Lane Birmingham, AL 35211-4464 Establishment Registration Number: 1062741

Julie Carlston Synovis Micro Companies Alliance, Inc. A Subsidiary of Baxter International Inc. 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7511 Fax: 651-642-9018 julie_carlston@baxter.com

Date Prepared: September 13, 2022

II. Subject Device K221843

Device Trade Name	GEM™ Biover Microvascular Clamps
Common Name	Microvascular Clamps
Classification Name	Clamp, VascularRegulation Number: 21 CFR 870.4450Classification: Class II
Product Code	DXC

III. Predicate Device K011208

Device Trade Name	Biover Microvascular Clamps
Common Name	Microvascular Clamps
Classification Name	Clamp, VascularRegulation Number: 21 CFR 870.4450Classification: Class II
Product Code	DXC

IV. Device Description

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V. Intended Use and Indications for Use

The Intended Use remains the same as the predicate device (K011208).

Indication for Use

GEM BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

The wording of the Indication for Use was modified slightly from the predicate to improve the clarity of the statement while maintaining the same intended use and scope. The indications for use statements are the same in intended clinical use and therefore there is no substantial change to the indication for use of the microvascular clamps. The similarity in the indication for use statements supports substantial equivalence.

VI. Comparison of Technological Characteristics with the Predicate Device

The device and primary packaging of the double pouch configuration (sterile packaging) remain unchanged and are identical to the predicate device. There are no engineering or performance changes to the device or its packaging. The only technology change is a minor modification to the sales unit carton (box of 10 individual pouches) which was made to ease removal of the packaged (pouched) clamps. There is no change in sterilization.

In addition to the minor change to the carton, updates were made to the Instruction Manual and package labeling to reflect the new tradename of the device.

Attribute	Subject of this submission	Predicate Device	Comparison
510(k) #	GEM BIOVER MicrovascularClamps	BIOVER Microvascular Clamps	-
Manufacturer(SpecificationDeveloper)	SYNOVIS MICRO COMPANIESALLIANCE, INC. (A Subsidiary OfBaxter International Inc.)439 Industrial LnBIRMINGHAM, AL 35211	Biover AGMuliweg 2Hergiswil Nidwalden, CH 114-002	Change due toacquisition ofBiover AG
ContractManufacturer	DIADEM CORPORATION582-7, Ubaga-ChoHitachiomiya-ShiIbaraki, JP 319-2251	DIADEM CORPORATION582-7, Ubaga-ChoHitachiomiya-ShiIbaraki, JP 319-2251	Same
Attribute	Subject of this submissionGEM BIOVER MicrovascularClamps	Predicate DeviceBIOVER Microvascular Clamps	Comparison
Intended Use	GEM BIOVER disposablemicrovascular clamps are usedin microsurgical procedures toocclude blood vessels duringanastomosis.	BIOVER disposablemicrovascular clamps are usedin microsurgical procedures toocclude blood vessels duringanastomosis.	Same
Indications for Use	Disposable microvascularclamps are instruments whichare used for all microsurgicalprocedures. They are used toocclude vessels duringanastomosis, which isnecessary as a result of vesseldamage or thrombosis.	BIOVER disposablemicrovascular clamps areused for end to endanastomotic procedures forarteries and veins. Thesingle version is placed tostop blood flow for a certaintime (less than 16 hours).The double version is usedfor the repair of rupturedarteries and veins.	Equivalent. Updateof tradename. Thedifferences inwording areclarifying theintended use of thedevice and do notconstitute achange in theirclinical use
General Description
Product UseEnvironment	Hospital	Hospital	Same
End Users ofProduct	Surgeons, scrubbed persons,and nurses	Surgeons, scrubbed persons,and nurses	Same
Clamp Design	2 Types of Clamps are available1) Clamps for arteries areyellow (single (1) anddouble (2))2) Clamps for veins aregreen (single (1) anddouble (2))	2 Types of Clamps are available1) Clamps for arteries areyellow (single (1) anddouble (2))2) Clamps for veins are green(single (1) and double (2))	Same
Vessel Diameter	Artery Clamps (yellow):< 1 mm,1 mm - 2 mm,2mm - 4mmVein Clamps (green):0.2 – 1 mm< 1 mm,1 mm-2 mm,2 mm	Artery Clamps (yellow):< 1 mm,1 mm - 2 mm,2mm - 4mmVein Clamps (green):0.2 – 1 mm< 1 mm,1 mm-2 mm,2 mm	Same
Contraindications	None known.	None known	Same
Labeling
Attribute	Subject of this submissionGEM BIOVER Microvascular Clamps	Predicate DeviceBIOVER Microvascular Clamps	Comparison
Labels andInstruction ManualforMonitor and PowerSupply	See section 13 - ProposedLabeling	See section 13 - ProposedLabeling	Equivalent.Labeling wasmodified to reflectthe new legalmanufacturer.Branding updatedto reflect newtradename.Indication for Usestatement updatedto reflect theclarified indicationfor use statement
Packaging	Each clamp is packaged in adouble Tyvek pouchconfiguration. 10 pouchespacked in an outer carton.	Each clamp is packaged in adouble Tyvek pouchconfiguration. 10 pouchespacked in an outer carton.	Same. Minorchange to theopening geometryof the outer cartonof the sales unithas no impact onthe device

Table 1: Predicate and subject device comparison

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VII. Performance Data

The label design change and the outer carton sales unit design change were assessed and validated in a Packaging Summative Human Factors/Usability Study. Historical complaint data were reviewed and indicate no use-related concerns, thus, there are no use-related risks or complaints that trigger a need for further Human Factors validation.

VIII. Conclusions

The GEM Biover microvascular clamps remain unchanged from the predicate device. Performance testing has been completed to evaluate safety and effectiveness of the subject device as it compares to its predicate. The conclusions drawn from the risk-benefit assessment and nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. The proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).