Vein Clamps, Artery Clamps

K161315 · Aros Surgical Instruments Corporation · DXC · Aug 18, 2016 · Cardiovascular

Device Facts

• Record ID: K161315
• Device Name: Vein Clamps, Artery Clamps
• Applicant: Aros Surgical Instruments Corporation
• Product Code: DXC · Cardiovascular
• Decision Date: Aug 18, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A surgical instrument used to occlude a blood vessel temporarily.

Device Story

Vein and Artery Clamps are small surgical instruments used to temporarily occlude blood vessels during surgical procedures. Operated by surgeons in clinical settings, these manual devices apply mechanical pressure to vessels to control blood flow. The device modification includes expanded closing pressure ranges (15 to 120 gms), the addition of a curved design option, and a transition to radiation sterilization. The device functions as a mechanical clamp; it does not involve electronic inputs, software, or automated processing. By providing controlled occlusion, the clamps assist surgeons in maintaining a clear surgical field and managing vascular access during procedures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including biocompatibility testing per ISO 10993, sterilization validation per ISO 11137, and mechanical compression studies to verify closing pressures.

Technological Characteristics

Manual vascular clamps; expanded closing pressure range of 15 to 120 gms; straight and curved design options; sterilization via radiation (ISO 11137); biocompatibility per ISO 10993.

Indications for Use

Indicated for use as a surgical instrument to temporarily occlude blood vessels in patients undergoing surgery.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Micro Anastomosis Clamps (K961100)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 18, 2016

AROS Surgical Instruments Corporation % Mr. Greg Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606

Re: K161315

Trade/Device Name: Vein Clamp and Artery Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: July 18, 2016 Received: July 19, 2016

Dear Mr. Greg Holland:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Brian D. Pullin -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K161315

Device Name Vein Clamp and Artery Clamp

| Indications for Use ( <i>Describe</i> ) | A surgical instrument used to occlude a blood vessel temporarily. |
|-----------------------------------------|-------------------------------------------------------------------|
|-----------------------------------------|-------------------------------------------------------------------|

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## K161315

### 5. 510(k) Summary

Image /page/3/Picture/2 description: The image shows the logo for AROSurgical Instruments Corporation. The word "AROSurgical" is in a stylized font with horizontal lines running through the letters. Below the word is the phrase "INSTRUMENTS CORPORATION" in a smaller, sans-serif font.

| Submission Date | May 9, 2016 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | AROS Surgical Instruments Corporation<br>2111 Descanso<br>Newport Beach, CA 92660<br>TEL: [phone]<br>FAX: [phone] |
| Contact Person | Greg Holland<br>Regulatory Consultant to AROS Surgical<br>Instruments Corporation<br>Regulatory Specialists, Inc.<br>3722 Ave. Sausalito<br>Irvine, CA 92606<br>TEL: [phone]<br>FAX: [phone]<br>EMAIL: [e-mail] |
| Establishment Registration | 2085887 |
| Common Name | Vascular Clamp |
| Trade Name | Vein Clamp and Artery Clamp |
| Classification Name | Clamp, Vascular |
| Regulation | 870.4450 |
| Class | II |
| Panel | Cardiovascular |
| Product Code | DXC |
| Associated FDA Numbers | K961100 |
| Reason for Submission | Device Modification |
| Predicate | K961100, Micro Anastomosis Clamps |
| Manufacturing Site | Bear Medic Corporation<br>1361 Chika-Machi, Daigomachi<br>Kuju Gun Ibaraki |

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319-35 Japan TEL: [phone] FAX: [phone]

Special Controls No applicable mandatory performance standards or special controls exist for this device

Description - The Vein Clamps and Artery Clamps are small clamps used in surgery on small blood vessels. This Special 510(k) is being done to expand on the pressures, add a curved design, and change the sterilization process. There are no other changes and the original products cleared under K961100 remain unchanged and are still being sold.

Intended Use - A surgical instrument used to occlude a blood vessel temporarily.

Indications for Use - A surgical instrument used to occlude a blood vessel temporarily

Technological Characteristics - This Special 510(k) is being done to expand on the pressures, add a curved design, and change the sterilization process.

Changes from the original 510(k), K961100

| | K961100 | Changes |
|-------------------|-----------------------------|--------------------|
| Closing Pressures | 19.8 to 60.1 gms | 15 to 120 gms |
| Design | All clamps were<br>straight | Adds curved design |
| Sterilization | Ethylene Oxide | Radiation |

- Testing Biocompatibility using ISO 10993 and FDA guidance document were successfully completed. Closing pressures were measured. Sterilization validation was done to ISO 11137.
Conclusions from non-clinical performance data

After performing non-clinical performance studies, Biocompatibility to ISO 10993, Sterilization Validations and Compression Studies, the data shows that the Vein Clamps and Artery Clamps are substantially equivalent to the predicate.