(63 days)
Not Found
Not Found
No
The summary describes a kit of standard surgical tools and a drug for lymphatic mapping, with no mention of AI or ML.
No
The device is indicated for lymphatic mapping, a diagnostic procedure, not for treating any condition.
Yes
The intended use explicitly states "lymphatic mapping," which is a diagnostic procedure to identify lymph nodes, typically those that may contain cancer cells, for removal or further examination.
No
The device description explicitly states the kit consists of 5 devices and a drug, indicating it includes hardware components and is not software-only.
Based on the provided information, the AUTO SUTURE* ILM** Procedure Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in lymphatic mapping." This is a procedure performed in vivo (within the living body) to identify lymphatic pathways.
- Device Description: The kit contains devices and a drug used during a surgical procedure.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions. The description doesn't mention any components or processes for analyzing biological samples in vitro.
The kit is designed for a surgical procedure involving the lymphatic system within the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The AUTO SUTURE* ILM** Procedure Kit has application in the surgical mapping of the lymphatic system.
The AUTO SUTURE* ILM** Procedure Kit is indicated for use in lymphatic mapping.
Product codes (comma separated list FDA assigned to the subject device)
FZP
Device Description
The Kit consists of 5 devices and a drug (see predicate device list) which are packaged together in accordance with their existing labeling and indications for use in lymphatic mapping procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lymphatic system
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)
Not Found
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.
AUTO SUTURE* Premium SURGICLIP*, Standard Hyperdermic Needle, Standard Syringe with LuerLock, Standard Sterile Marking Pen, Standard Surgical Ruler, DRUG-Lymphazurin Blue
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K971201
giourilisatore italia. Italia.
SUBMITTER:
ENCLOSURE I 510(k) SUMMARY AND SAFETY AND EFFECTIVENESS
United States Surgical Corporation
JUN - 3 1997
| SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Victor Clavelli |
| DATE PREPARED: | May 21, 1997 |
| CLASSIFICATION: | Procedure Kit |
| COMMON NAME: | Lymphatic Mapping Kit |
| PROPRIETARY NAME: | Not yet determined |
| PREDICATE DEVICES: | AUTO SUTURE* Premium SURGICLIP*
Standard Hyperdermic Needle
Standard Syringe with LuerLock
Standard Sterile Marking Pen
Standard Surgical Ruler
DRUG-Lymphazurin Blue |
| KIT DESCRIPTION: | The Kit consists of 5 devices and a drug (see predicate
device list) which are packaged together in accordance
with their existing labeling and indications for use in
lymphatic mapping procedures. |
| INTENDED USE: | The AUTO SUTURE* ILM** Procedure Kit has
application in the surgical mapping of the lymphatic
system. |
| MATERIALS: | All of the device contained within this kit are currently
marketed instruments which are composed entirely of
biocompatible materials which are in compliance with ISO
10993-1 for their intended patient contact profile. |
1
Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is in black and white and appears to be a scanned image.
JUN - 3 1391
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Victor Clavelli Senior Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K971201 Trade Name: Auto Suture* ILM** Kit Regulatory Class: Class II Product Code: FZP Dated: March 31, 1997 Received: April 1, 1997
Dear Mr. Clavelli:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your
2
Page 2 - Mr. Victor Clavelli
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.
In addition, we have determined that your device kit contains Lymphazurin which is subject to --regulation as a drug.
Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063
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 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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,
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
ENCLOSURE II
INDICATIONS FOR USE
11, 19
510(k) Number (if known): [K971201](https://510k.innolitics.com/search/K971201)
Device Name: AUTO SUTURE* ILM** Procedure Kit
Indications-For Use:
The AUTO SUTURE* ILM** Procedure Kit is indicated for use in lymphatic mapping.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODF Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)