(90 days)
Not Found
No
The device description and intended use are for a simple, non-electronic finger guard. There is no mention of AI, ML, or any computational processing.
No
The device is described as a finger guard for protection during surgery, which is a protective barrier, not a device intended to treat or ameliorate a disease or condition. Its function is to protect the wearer, not to treat a patient.
No
The device is described as a finger guard for protection during suture tensioning and knot tying, not for diagnosing any medical condition.
No
The device description clearly states it is a physical product made of woven polyester with a marker thread, intended for physical protection during surgery. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical protection of the wearer's fingers during surgical procedures involving suture tensioning and knot tying. This is a physical barrier and protective function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details a physical barrier made of woven polyester. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for personal protection during a surgical procedure, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex Fingershield finger quards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.
Product codes
LZB
Device Description
The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
NOV 2 9 2005
510(k) Summary
| 510(k) Number: | |
|---|---|
| Company: | Arthrex, Inc. |
| Address: | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | (239) 643-5553 |
| Facsimile: | (239) 598-5508 |
| Contact: | Ann Waterhouse |
| Device Name: | Arthrex Fingershield |
| Classification: | Finger Cot |
| Product Code: | LZB |
| Regulation #: | 21 CFR 880.6250 |
Description:
The Arthrex Fingershield Finger Guards are woven polyester with a marker thread of radio opaque Micropake®. These are offered in a one size fits all cylinder shape. They are offered sterile.
Indications for Use:
The Arthrex Fingershield finger quards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.
Substantially Equivalent Product:
Percuguard by Digit-Pro, K992539 Latex Finger Cot by Tucker & Associates, K980827
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device for the previously cleared indications. The materials used in construction of these devices are well characterized in regards to strength and biocompatibility. The Arthrex Fingershield finger guards do not raise any questions regarding safety and effectiveness.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem depicts a stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is simple and monochromatic.
NOV 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex, Incorporated 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K052387
Trade/Device Name: Arthrex Fingershield Finger Guard Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZB Dated: November 10, 2005 Received: November 14, 2005
Dear Ms. Waterhouse:
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.
2
Page 2 - Ms. Waterhouse
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), n Jose contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours.
Syndie Y. Michael Omd
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Arthrex Fingershield Finger Guard
Indications for Use:
The Arthrex Fingershield finger guards are intended to be used over surgical gloves for the protection of wearer while tensioning suture or tying knots with suture products.
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
page 1 of
Shule H. Murphy, hQ 4/24/05
Ansion of Anesthes ... ory. General Hospital. infaction Control. Declai
2(k) Number: K 052387