(33 days)
Allegiance Healthcare's Fogarty Surgical Clamp, Baxter International's Safejaw Inserts
Not Found
No
The summary describes a mechanical surgical clamp and jaw inserts, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as a surgical clamp used for vascular and gastrointestinal work, performing occlusion of vessels and bowel. These actions are intended to treat conditions and restore function, aligning with the definition of a therapeutic device.
No
The device, a surgical clamp, is used for occluding vessels and bowel during surgery. Its function is interventional (to facilitate surgery) rather than diagnostic (to identify or analyze a condition).
No
The device description explicitly states "Slimline Surgical Clamp and Slimline Jaw Inserts," which are physical hardware components. The intended use also describes the function of a physical clamp.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Slimline Surgical Clamp and Slimline Jaw Inserts" used for surgical procedures on vascular and gastrointestinal structures. It is a physical tool used during surgery to manipulate and occlude vessels and bowel.
- Lack of Diagnostic Activity: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on biological specimens.
The device is a surgical instrument used for therapeutic purposes (occlusion during surgery), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For Vascular Work
- Suitable for veins and arteries. .
- Performs efficiently on either diseased or normal vessels. - Provides occlusion of atherosclerotic vessels without excessive closing . forces.
- Minimizes intimal damage and fragmentation of atherosclerotic material. - Can be clamped over indwelling catheters. .
For Gastrointestinal Work - Replaces bulky, rubber shod clamps .
- Cushion-design of inserts enables occlusion without crushing the bowel. .
Product codes
DXC
Device Description
Minumys' Slimline Surgical Clamp and Slimline Jaw Inserts are a Class II medical device. The common name for Minumys' device is: Surgical Clamp. Minumys' Slimline Surgical Clamp with Slimline Jaw Inserts and Allegiance's Fogarty Surgical Clamp with Baxter's Safejaw Inserts are surgical clamps intended for use in vascular or general surgery. The Slimline Surgical Clamp and Slimline Jaw Inserts are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics, and target population of surgical disciplines. The princible of operation for occlusion with these clamps is the squeezing together of the jaws to temporarily occlude vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, bowel, veins and arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical disciplines, vascular or general surgery
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Allegiance Healthcare's Fogarty Surgical Clamp, Baxter International's Safejaw Inserts
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
Ky42600
SEP 18 1999
510(K) SUMMARY
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 1390 Piccard Drive Rockville, MD 20850
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR §807.92.
Minumys Surgical intends to introduce into commercial distribution the Slimline Surgical Clamp and Slimline Jaw Inserts. The equivalent predicate devices are Allegiance Healthcare's Fogarty Surgical Clamp (preamendment) and Baxter International's Safejaw Inserts (see copy of Product Insert Sheet in Attachment 2).
The FDA has classified surgical instruments for clamping as Class I devices (21CFR878-4800). The FDA has also classified vascular clamps as Class II devices (21CFR870-4450). Minumys' Slimline Surgical Clamp and Slimline Jaw Inserts are a Class II medical device. The common name for Minumys' device is: Surgical Clamp.
Minumys' Slimline Surgical Clamp with Slimline Jaw Inserts and Allegiance's Fogarty Surgical Clamp with Baxter's Safejaw Inserts are surgical clamps intended for use in vascular or general surgery. The Slimline Surgical Clamp and Slimline Jaw Inserts are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics, and target population of surgical disciplines.
The princible of operation for occlusion with these clamps is the squeezing together of the jaws to temporarily occlude vessels. The need for clamping is present in most surgical specialties. The device labeling supports the use of these devices for vascular and general surgical applications in surgery.
Kermit R. Pope, Jr. Date
8/2/99
Kermit R. Pope President/CEO Date
Minumys Surgical 10231 Bubb Road Cupertino, CA 95014 (408) 873-3161
1
Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP == 8 1999
Mr. Noel Messenger Regulatory Consultant Minumys Surgical, Inc. 10231 Bubb Road Cupertino, California 95014
Re: K992640
Trade Name: SlimLine Surgical Clamp and SlimLine Jaw Inserts Regulatory Class: II Product Code: DXC Dated: July 28, 1999 Received: August 6, 1999
Dear Mr. Messenger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Noel Messenger
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
pcoolly
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 (k) Number: K992640
Device Name: SlimLine Surgical Clamp and SlimLine Jaw Inserts
Indications For Use
For Vascular Work
- Suitable for veins and arteries. .
- Performs efficiently on either diseased or normal vessels. ●
- Provides occlusion of atherosclerotic vessels without excessive closing . forces.
- Minimizes intimal damage and fragmentation of atherosclerotic material. ●
- Can be clamped over indwelling catheters. .
For Gastrointestinal Work
- Replaces bulky, rubber shod clamps .
- Cushion-design of inserts enables occlusion without crushing the bowel. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K992640 |
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| ------------------ | --------------- | ---- | ---------------------- | --------------- |