(76 days)
Not Found
No
The summary describes a mechanical device used during surgery and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as assisting in surgical procedures (coronary artery bypass grafting) which are therapeutic interventions. Its function to replace partial occluding clamps directly impacts the patient's physiological state during surgery, making it a therapeutic device.
No
The device is described as an "Anastomosis Assist Device" used during CABG procedures to assist in creating anastomosis sites, replacing partial occluding clamps. Its function is procedural assistance rather than diagnosis.
No
The device description explicitly states it is an "intraoperative device" and a "modified ENclose™ Anastomosis Assist Device," implying a physical component used during surgery, not solely software. The predicate device is also a "Vascular Clamp," further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use by cardiac surgeons during coronary artery bypass grafting (CABG) procedures. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description reinforces that it is an intraoperative device used to assist in creating anastomosis sites during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the ENclose™ Anastomosis Assist Device is a surgical device used directly on a patient during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ENclose™ Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three anastomoses in ascending aortas free of atheromatous disease.
Product codes
DXC
Device Description
The change is limited to a request for multiple use. The modified ENclose™ Anastomosis Assist Device is a intraoperative device used to assist in the creation of one or more proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aortas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiac surgeons
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)
Clinical Testing Summary. Clinical testing conducted in Canada and Europe demonstrate the functional equivalence of the added ENclose™ Anastomosis Assist Device. The one to three vessel use ENCLOSE™ Anastomosis Assist Devices' level of performance is substantially equivalent to the existing legally marketed ENCLOSE™ Anastomosis Assist Device (InCluder™, K010694) cleared for single vessel use. The collected clinical data demonstrate that one to three proximal anastomoses are no more difficult and are just as safe as the existing single anastomosis procedure performed using the previously cleared ENCLOSE™ Anastomosis Assist Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JAN 1 6 2003
| Summary of Safety Information | NOVARE SURGICAL SYSTEMS, INC. | K023682
JANUARY 15, 2003 |
|----------------------------------------|-------------------------------------------------|-----------------------------|
| Premarket Notification, Section 510(k) | | |
| Regulatory Authority: | Safe Medical Devices Act of 1990, 21 CFR 807.92 | |
| Device Name: | ENclose™ Anastomosis Assist Device | |
| Common Name(s): | Vascular Clamp | |
| Classification Name(s): | Vascular Clamp | |
| Manufacturer: | | |
| Name: | Novare Surgical Systems, Inc. | |
| Number: | 2954739 | |
| Address: | 10231 Bubb Road
Cupertino, CA 95014 | |
| Classification(s): | | |
Sec. 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).
| Device Class: | Class II for the requested indications |
|---|---|
| Classification Panel: | Cardiovascular Devices Panel |
| Product Code(s): | DXC |
Equivalent Predicate Device:
The ENclose™ Anastomosis Assist Device is substantially equivalent to the following legally marketed vascular clamp:
1. InCluder™ Vascular Clamp - Novare Surgical Systems, Inc., K010694
Sec. 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).
| Device Class: | Class II |
|---|---|
| Product Code(s): | DXC |
The new anastomosis device is identical to the previous device. Equivalency can be seen with respect to place of manufacture, physical appearance, functional testing, material certification, surgical technique and indications for use. A feature comparison chart follows this section.
| FEATURE | ENclose™ Anastomosis Assist Device | Includer™ Vascular Clamp -K010694 | SE? |
|---|---|---|---|
| Indications for Use: | The ENclose™ Anastomosis Assist Device is intended | ||
| for use by cardiac surgeons in place of partial occluding | |||
| clamps during coronary artery bypass grafting (CABG) | |||
| procedures requiring one to three proximal anastomoses | |||
| in ascending aortas free of atheromatous disease. | Identical, except single anastomosis | YES | |
| Materials: | Medical grade plastic, stainless steel and silicone | Identical | YES |
| Design: | Clamp | Identical | YES |
| Sterilization: | Radiation (e-beam) | Identical | YES |
| Manufacturer: | Novare Surgical Systems, Inc. | Identical | YES |
| Product Code: | DXC | Identical | YES |
| K - Number: | K023682 | K010694 | YES |
1
Device Description:
The change is limited to a request for multiple use. The modified ENclose™ Anastomosis Assist Device is a intraoperative device used to assist in the creation of one or more proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG).
Clinical Testing Summary. Clinical testing conducted in Canada and Europe demonstrate the functional equivalence of the added ENclose™ Anastomosis Assist Device. The one to three vessel use ENCLOSE™ Anastomosis Assist Devices' level of performance is substantially equivalent to the existing legally marketed ENCLOSE™ Anastomosis Assist Device (InCluder™, K010694) cleared for single vessel use. The collected clinical data demonstrate that one to three proximal anastomoses are no more difficult and are just as safe as the existing single anastomosis procedure performed using the previously cleared ENCLOSE™ Anastomosis Assist Device.
Please refer to the product instructions for use for a more complete listing of indications, warnings, cautions and precautions.
Company Contact:
Mr. Kerry Pope Novare Surgical Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 408.873.3161
Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
Snecial Controls:
Special controls were published by FDA. The following special controls are believed to apply to the marketing of class II devices:
- (i) Compliance with material standards,
- (ii) Compliance with biocompatability standard, and Compliance with specified labeling requirements.
Novare Surgical Systems, Inc. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
Sterility Processing:
The ENclose™ Anastomosis Assist Device is provided sterile and is designed strictly for single patient use. The device may not be cleaned, reprocessed or reused under any circumstances. The product must be handled, stored and placed into use in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following accepted surgical sterile technique.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 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 symbol of three human profiles facing to the right, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2003
Novare Surgical Systems, Inc. c/o Mr. David Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389
Re: K023682
Enclose™ Anastomosis Assist Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: October 31, 2002 Received: November 1, 2002
Dear Mr. Schlerf:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. David Schlerf
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nalgtleh
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 - of of of l
K023682 510(k) Number:
ENclose™ Anastomosis Assist Device Device Name(s):
Indication(s) for Use:
The ENclose™ Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three anastomoses in ascending aortas free of atheromatous disease.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Nolen Tull
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K023682
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)