(99 days)
Not Found
No
The 510(k) summary describes a mechanical surgical instrument (clamps) and focuses on changes to pressure, design, and sterilization. There is no mention of AI, ML, image processing, or data-driven algorithms.
No.
The clamps are used to occlude a blood vessel temporarily, which is a supportive surgical function rather than a therapeutic one that treats or cures a disease directly.
No
Explanation: The device is a surgical instrument used to occlude blood vessels, which is a therapeutic function, not a diagnostic one. It does not gather information about a patient's health condition.
No
The device description explicitly states it is a surgical instrument (clamps) and discusses physical attributes like pressure, design, and sterilization, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A surgical instrument used to occlude a blood vessel temporarily." This describes a physical action performed on the body during surgery.
- Device Description: The description clearly states it's a "surgical instrument" used "in surgery on small blood vessels."
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not interact with specimens in this way.
- Anatomical Site: The anatomical site is "blood vessel," indicating it's used directly on the patient's anatomy.
The description and intended use clearly place this device in the category of a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A surgical instrument used to occlude a blood vessel temporarily.
Product codes (comma separated list FDA assigned to the subject device)
DXC
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.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
§ 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).
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 ( 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)
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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 |
| 2111 Descanso | |
| Newport Beach, CA 92660 | |
| TEL: 949-640-9932 | |
| FAX: 949-640-9934 | |
| Contact Person | Greg Holland |
| Regulatory Consultant to AROS Surgical | |
| Instruments Corporation | |
| Regulatory Specialists, Inc. | |
| 3722 Ave. Sausalito | |
| Irvine, CA 92606 | |
| TEL: 949.422.3853 | |
| FAX: 949.552.2821 | |
| EMAIL: greg@regulatoryspecialists.com | |
| 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 |
| 1361 Chika-Machi, Daigomachi | |
| Kuju Gun Ibaraki |
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319-35 Japan TEL: 81-295 72 1811 FAX: 81-295 72 4157
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 | |
| 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.