Vein Clamps, Artery Clamps

• K Number: K161315
• Device Name: Vein Clamps, Artery Clamps
• Manufacturer: AROS Surgical Instruments Corporation
• Date Cleared: 2016-08-18 ( 99 days)
• Product Code: DXC
• Regulation Number: 870.4450
• Type: Special
• Panel: Cardiovascular
• Reference & Predicate Devices: K961100
• Predicate For: K230281

Intended Use

A surgical instrument used to occlude a blood vessel temporarily.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Vein Clamp and Artery Clamp" and discusses the changes from a previous clearance (K961100). However, the document does not contain specific acceptance criteria, comprehensive study details, or quantifiable performance data in the format requested. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Based on the provided information, here's what can be extracted and what is missing:

---

Acceptance Criteria and Study Details for AROS Surgical Instruments Corporation's Vein Clamp and Artery Clamp (K161315)

The provided document describes a Special 510(k) submission for the Vein Clamp and Artery Clamp, which expands on pressures, adds a curved design, and changes the sterilization process from the original K961100 clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Not Explicitly Stated as AC in Doc)	Reported Device Performance (as updated)
Closing Pressures	Original: 19.8 to 60.1 gms (Implied benchmark from predicate)	15 to 120 gms (Expanded range)
Design	Original: All clamps were straight (Implied benchmark from predicate)	Adds curved design
Sterilization Method	Original: Ethylene Oxide (Implied benchmark from predicate)	Radiation (New method)
Biocompatibility	ISO 10993 and FDA guidance document compliance	Successfully completed (Statement of compliance)
Sterilization Validation	ISO 11137 compliance	Successfully completed (Statement of compliance)

Note: The document explicitly states the changes from the predicate device (K961100) rather than setting up formal acceptance criteria. The "acceptance criteria" above are inferred from the previously cleared device's characteristics, and the "reported device performance" reflects the modifications being introduced and tested.

2. Sample Size for Test Set and Data Provenance

The document does not specify the sample size used for any of the non-clinical tests (e.g., in a "test set" for closing pressure measurements, biocompatibility, or sterilization validation).

The data provenance is not mentioned beyond the fact that testing was conducted to demonstrate compliance with standards like ISO 10993 and ISO 11137. It is implicitly prospective from the perspective of validating the new design and sterilization method, but no country of origin for specific test data is provided.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This is a medical device (vascular clamp) and the evaluation is based on engineering and materials testing, not diagnostic performance requiring expert consensus on images or clinical data.

4. Adjudication Method for Test Set

Not applicable. This type of device verification does not typically involve adjudication by human experts in the way clinical studies for diagnostic tools do. Tests are objective and measurable (e.g., force, sterility).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a surgical instrument, not a diagnostic imaging tool or an AI-powered diagnostic aide. Therefore, an MRMC study is not relevant.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical surgical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through adherence to recognized international standards and objective physical measurements:

• Biocompatibility: Demonstrated by testing according to ISO 10993 and FDA guidance.
• Sterilization: Validated according to ISO 11137.
• Closing Pressures: Measured physical forces of the clamps.

8. Sample Size for Training Set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161315

Device Name Vein Clamp and Artery Clamp

Indications for Use ( Describe )	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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 Corporation2111 DescansoNewport Beach, CA 92660TEL: [phone]FAX: [phone]
Contact Person	Greg HollandRegulatory Consultant to AROS SurgicalInstruments CorporationRegulatory Specialists, Inc.3722 Ave. SausalitoIrvine, CA 92606TEL: [phone]FAX: [phone]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 Corporation1361 Chika-Machi, DaigomachiKuju Gun Ibaraki

{4}------------------------------------------------

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 werestraight	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.

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).