(63 days)
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.
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.
This looks like a 510(k) premarket notification for a medical device kit, specifically a "Lymphatic Mapping Kit." Based on the provided text, the submission focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a performance study with acceptance criteria in the typical sense of a novel AI/software medical device.
Therefore, many of the requested points regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document, as this type of submission generally relies on demonstrating that the new device's components and intended use are similar to already legally marketed devices.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided: This document does not present specific quantitative acceptance criteria or a performance study with reported device performance metrics (e.g., sensitivity, specificity, accuracy) for the kit as a whole. The substantial equivalence is based on the components and their existing labeling.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: No performance study data is presented for a test set. This submission is for a kit composed of existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided: No ground truth establishment is described, as no specific performance study on a test set is documented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable/Not Provided: This document describes a kit of existing medical devices, not an AI or software-based device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Provided: This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: No performance study that would require ground truth is described.
8. The sample size for the training set
- Not Applicable/Not Provided: No training set is relevant as this is not an algorithm/AI device.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: No training set or ground truth establishment relevant to training is described.
Summary from the document:
This 510(k) submission (K971201) is for a Procedure Kit named "AUTO SUTURE* ILM** Procedure Kit" intended for "surgical mapping of the lymphatic system." It is a kit composed of several already marketed devices (predicate devices), including:
- AUTO SUTURE* Premium SURGICLIP*
- Standard Hyperdermic Needle
- Standard Syringe with LuerLock
- Standard Sterile Marking Pen
- Standard Surgical Ruler
- DRUG-Lymphazurin Blue
The submission argues for substantial equivalence based on the fact that the components 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" and that they are "packaged together in accordance with their existing labeling and indications for use in lymphatic mapping procedures."
The FDA's response confirms substantial equivalence for the device components of the kit, but notes that "Lymphazurin which is subject to --regulation as a drug" and the "substantially equivalent determination does not apply to the drug component of your device." The submitter is advised to contact the Center for Drug Evaluation and Research regarding the drug component.
Key takeaway: This document is a regulatory submission for a physical medical device kit seeking substantial equivalence to existing devices. It is not a performance study for a novel device, especially not an AI/software device, and therefore does not contain the information requested in your prompt regarding acceptance criteria and study results.
{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 Corporation150 Glover AvenueNorwalk, 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 NeedleStandard Syringe with LuerLockStandard Sterile Marking PenStandard Surgical RulerDRUG-Lymphazurin Blue |
| KIT DESCRIPTION: | The Kit consists of 5 devices and a drug (see predicatedevice list) which are packaged together in accordancewith their existing labeling and indications for use inlymphatic mapping procedures. |
| INTENDED USE: | The AUTO SUTURE* ILM** Procedure Kit hasapplication in the surgical mapping of the lymphaticsystem. |
| MATERIALS: | All of the device contained within this kit are currentlymarketed instruments which are composed entirely ofbiocompatible materials which are in compliance with ISO10993-1 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/device/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)
§ 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.