(85 days)
Smith + Nephew Richards Ilizarov System, AME PinCare Management System
Not Found
No
The summary describes a physical kit for wound care and does not mention any software, image processing, or AI/ML terms.
No
The Pin Care Kit is a cleaning and protection system for pin site wounds, which is a supportive care product rather than a device intended to treat or prevent a disease or condition.
No
The device is intended for cleaning and protection of pin site wounds, which is a treatment/management function, not a diagnostic one. It helps patients manage their wounds, not identify a disease or condition.
No
The device description explicitly states it is a "comprehensive system" and mentions a "Pin Care Kit," which strongly implies the inclusion of physical components (e.g., cleaning supplies, dressings) in addition to any potential software elements. The intended use also describes a physical process ("cleaning and protection of pin site wounds").
Based on the provided information, the Pin Care Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for cleaning and protection of pin site wounds, which are external wounds on the body. This is a direct interaction with the patient's body and not the examination of specimens derived from the human body.
- Device Description: The description focuses on managing pin site wounds at home, again indicating a direct patient care application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Pin Care Kit's function falls under wound care and management, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Pin Care Kit is intended for cleaning and protection of pin site wounds for patients with external fixation devices (halos, Ilizarov®, etc.). The Pin Care Kit is intended to enable patients to manage their own pin site wounds at home.
The Pin Care Kit is designed for use by patients wearing external The Fin Care Rit is designe them manage their own pin site wounds.
Product codes
EFO
Device Description
The Pin Care Kit is a comprehensive system designed to allow patients with external orthopedic fixation devices to manage their own pin site wounds at home.
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
patients with external orthopedic fixation devices to manage their own pin site wounds at home.
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)
Smith + Nephew Richards Ilizarov System, AME PinCare Management System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for Brown Medical Industries. The logo features a stylized graphic to the left of the text. The text is stacked, with "MEDICAL" above "INDUSTRIES".
Attachment I
NOV 26 1997
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 1. Submitted by: | | Brown Medical Industries
Lakes Business Park
1300 Lundberg Drive West
Spirit Lake, IA 51360-7246 |
|--------------------|--|-----------------------------------------------------------------------------------------------------------|
| Contact: | | Bob Petrosenko
Director, New Product Development |
| Phone: | | (712) 336-4395 |
| Date Prepared: | | August 27, 1997 |
| 2. Name of Device: | | Pin Care Kit |
| Common/Usual Name: | | Unknown |
| Classification: | | Unclassified |
-
Identification of predicate or legally marketed device or devices to which substantial equivalence claimed: Smith + Nephew Richards Ilizarov System, AME PinCare Management System.
-
Description of Device: The Pin Care Kit is a comprehensive system designed to allow patients with external orthopedic fixation devices to manage their own pin site wounds at home.
-
Intended Use of the Device: The Pin Care Kit is intended for cleaning and protection of pin site wounds for patients with external fixation devices (halos, Ilizarov®, etc.). The Pin Care Kit is intended to enable patients to manage their own pin site wounds at home.
-
The Pin Care Kit has the same design, materials, function and intended use as the aforementioned devices.
Dok Patrasenka
Bob Patrasenka
August 27/97
Date
Bob Petrosenko
es Business Park • 1300 Lundberg Drive West • Spirit Lake, IA 51360-7246 USA
712-336-4395 • 800-843-4395 • FAX 712-336-2874
bmi@rconnect.com • www.brownmed.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bob Petrosenko, MS BME Director. New Products Development Brown Medical Industries Lakes Business Park 1300 Lundberg Drive West Spirit Lake, Iowa 51360-7246
NOV 26 1997
Re: K973299 Trade Name: Pin Care Kit Regulatory Class: Unclassified Product Code: EFO Dated: August 27, 1997 Received: September 2, 1997
Dear Mr. Petrosenko:
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
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comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
In addition, we have determined that your device kit contains Sterile Water for Irrigation 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- 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
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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
4
Page of
K973299 510(k) Number (if known):_
Pin Care Kit Device Name:_
Indications For Use:
The Pin Care Kit is designed for use by patients wearing external The Fin Care Rit is designe them manage their own pin site wounds.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Re 510(k) Number ﺨﻴﺮ ﺍﻟﻤﺮﺍﺟﻊ ૦ર્વ Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)