(364 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial function of the sleeve, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is intended to inhibit bacterial colonization on pins/wires during external bone fixation, which is a prophylactic measure rather than a therapeutic treatment for an existing condition.
No
The device is an antimicrobial sleeve intended to inhibit bacterial colonization on orthopaedic pins/wires. It is a therapeutic/preventative device, not a diagnostic one.
No
The device description clearly outlines a physical product made of polyurethane tubing with an antimicrobial coating. The performance studies also focus on physical and chemical properties of the material, not software performance.
Based on the provided information, the OrthoGuard AB Antimicrobial Sleeve is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to be an accessory surrounding orthopaedic pins and wires during external fixation of bones to inhibit bacterial colonization on the pin/wire. This is a direct interaction with the patient's body (in vivo) to prevent infection, not a test performed on a sample taken from the body (in vitro) to diagnose a condition.
- Device Description: The device is a physical sleeve coated with an antimicrobial substance, designed to be placed on a medical device used within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely preventative and mechanical/chemical in nature, acting on the surface of the pin/wire.
Therefore, the OrthoGuard AB Antimicrobial Sleeve falls under the category of a medical device used in vivo, not an in vitro diagnostic device.
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.
The OrthoGuard AB Antimicrobial Sleeve is provided at a maximum length for the longest pin/wire length and can be cut to desired lengths for smaller lengths of pins and wires selected for bone fixation. OrthoGuard AB Antimicrobial Sleeves are available in splined (longitudinal internal ridges for interference fit) or non-splined design in various diameters to match currently marketed orthopaedic pin/wire diameters.
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 OrthoGuard AB Antimicrobial Sleeve was subjected to the following testing and analyses: in-vitro elution tests, in-vivo elution tests. ETO sterilization study, packaging integrity test, ETO residual tests, product design configuration tests, coating adherence/consistency/conformity tests, microbial activity tests, antimicrobial release rate tests, fatigue (in-vitro) tests, product stability tests, biocompatibility tests, and quality control tests. The data from these tests 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.
K994143, K961433, K900263, K965178, K863354, K961392
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
KO12193
JUL 11 2002
510(k) Summary of Safety and Effectiveness OrthoGuard AB Antimicrobial Sleeve
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|---------------------------------------------------------------------------------------|
| Date: | 9 July 2002 |
| Contact Person: | Jeff F. Doerzbacher
Manager, Clinical/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 Sleeve is similar to the following devices:
Smith & Nephew External Fixation System (K994143) EBI X Dyna Fix System SC Bone Screws (K961433) Antimicrobial Multi-Lumen Central Venous Catheter (K900263) Niagara Dialysis Catheter (K965178) Bio-Guard AB Coated Catheter (K863354) Antimicrobial Peritoneal Dialysis Coil Catheter (K961392)
All of the devices listed above are either used for orthopaedic use and/or contain antimicrobial agents, and are considered substantially equivalent to the OrthoGuard AB Antimicrobial Sleeve.
112
1
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.
The OrthoGuard AB Antimicrobial Sleeve is provided at a maximum length for the longest pin/wire length and can be cut to desired lengths for smaller lengths of pins and wires selected for bone fixation. OrthoGuard AB Antimicrobial Sleeves are available in splined (longitudinal internal ridges for interference fit) or non-splined design in various diameters to match currently marketed orthopaedic pin/wire diameters.
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 Characteristics
Although the OrthoGuard AB Antimicrobial Sleeve is not identified predicate devices, the intended use and material composition are substantially equivalent to the characteristics found in one or more of the legally marketed predicate devices. Any differences that exist do not significantly affect the safety and effectiveness of the OrthoGuard AB Antimicrobial Sleeve
Performance Characteristics
The OrthoGuard AB Antimicrobial Sleeve was subjected to the following testing and analyses: in-vitro elution tests, in-vivo elution tests. ETO sterilization study, packaging integrity test, ETO residual tests, product design configuration tests, coating adherence/consistency/conformity tests, microbial activity tests, antimicrobial release rate tests, fatigue (in-vitro) tests, product stability tests, biocompatibility tests, and quality control tests. The data from these tests support the safety and effectiveness of the device and substantial equivalence to legally marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville: MD 20850
JUL 11 2002
Mr. Jeff F. Doerzbacher Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K012193
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, NJA Dated: May 15, 2002 Received: May 16, 2002
Dear Mr. Doerzbacher;
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. Jeff F. Doerzbacher
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 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,
Stpt Rhodes
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
4
Premarket Notification Indications Enclosure
510(k) Number: K012193
Page 1 of
Device Name: OrthoGuard AB Antimicrobial Sleeve
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Styet Plurdy
(Division Sign-Off Division of Genera. Restorative and Neurological Du . Rees
510(k) Number_________________________________________________________________________________________________________________________________________________________________