(42 days)
Not Found
No
The summary describes a physical device with an antimicrobial coating and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is intended to inhibit bacterial colonization, which is a preventative measure, not a therapeutic treatment for an existing condition.
No
Explanation: The device is an antimicrobial sleeve intended to inhibit bacterial colonization on orthopaedic pins/wires. Its function is preventative and therapeutic (inhibiting bacterial growth), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it consists of "polyurethane tubing coated... with an antimicrobial coating," indicating it is a physical device, not software.
Based on the provided information, the OrthoGuard AB Antimicrobial Sleeve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an accessory used during external fixation of bones to inhibit bacterial colonization on the pin/wire. This is a direct interaction with the patient's body (or the medical device inserted into the body), not a test performed in vitro (outside the body) on a sample.
- Device Description: The description details a physical sleeve with an antimicrobial coating, designed to be placed around pins and wires. This is a physical device, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information based on laboratory testing.
IVDs are typically used to examine specimens like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. The OrthoGuard AB Antimicrobial Sleeve's function is to prevent bacterial growth on a medical device used in a surgical procedure.
N/A
Intended Use / Indications for Use
The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pin/wire.
Product codes (comma separated list FDA assigned to the subject device)
JEC, NJA
Device Description
The OrthoGuard AB Antimicrobial Sleeve consists of polyurethane tubing coated on the inner and outer surfaces with an antimicrobial coating of gentamicin complexed with lauryl sulfate in a matrix of nitrocellulose and polyurethane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones
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)
The technological and performance characteristics of the OrthoGuard AB Antimicrobial Sleeve were compared to the predicate device. The results of this comparison support the safety and effectiveness of the device and substantial equivalence to legally marketed devices.
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness OrthoGuard AB Antimicrobial Sleeve
Ka226 76
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|---------------------------------------------------------------------------------------|
| Date: | August 7, 2002 |
| Contact Person: | Janet Johnson Green
Director, Regulatory Affairs |
| Proprietary Name: | OrthoGuard AB Antimicrobial Sleeve |
| Common Name: | Antimicrobial Pin/Wire Sleeve |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation
fastener (21 CFR 888.3040) |
| Device Product Code and Panel Code: | JEC / NJA - Orthopedics/87 |
Predicate Device / Substantial Equivalence Information
The OrthoGuard AB Antimicrobial Wire Sleeve is similar to the OrthoGuard AB Antimicribial Pin Sleeves included in 510(k) K012193. The following properties of the wire sleeve are the same as for the pin sleeves currently offered: intended use, material and coating formulation, manufacturing and coating method, labeling, and sterilization method. While the OrthoGuard AB Antimicrobial Wire Sleeve is not identical to the predicates, any differences that may exist do not significantly affect the safety or effectiveness. Therefore, the OrthoGuard AB Antimicrobial Wire Sleeve is substantially equivalent to the predicate devices.
Device Description
The OrthoGuard AB Antimicrobial Sleeve consists of polyurethane tubing coated on the inner and outer surfaces with an antimicrobial coating of gentamicin complexed with lauryl sulfate in a matrix of nitrocellulose and polyurethane.
Intended Use
The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pin/wire.
Technological and Performance Characteristics
The technological and performance characteristics of the OrthoGuard AB Antimicrobial Sleeve were compared to the predicate device. The results of this comparison support the safety and effectiveness of the device and substantial equivalence to legally marketed devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the three branches of government. The logo is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2002
Ms. Janet Johnson Green Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K022676
Trade/Device Name: OrthoGuard AB Antimicrobial Sleeve Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC and NJA Dated: August 8, 2002 Received: August 12, 2002
Dear Ms. Green:
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.
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.
2
Page 2 -- Ms. Janet Johnson Green
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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). 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.
Mark n Millan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
OrthoGuard AB Antimicrobial Sleeve Indications Statement
The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pine/wire.
Mark N. Mulkeron
Mivicia al. Restorative Division C and Neurological L evices
510(k) Number: K022676