(159 days)
- It is the intention of Miltex Inc. to introduce into the marketplace a line of Fixation/Steinmann Pins both Smooth and Threaded.
- The material is 316LVM, Stainless Steel and the Pins are to be utilized for internal fixation of bone fractures.
- The Pins are used specifically for fractures of the proximal or distal end of long bones such as intracapsular intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur.
- The device(s) may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Steinmann and Fixation Pins, Smooth and Threaded. The material is 316LVM, Stainless Steel.
The provided text describes a 510(k) summary for Steinmann and Fixation Pins and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or benchmark study.
Instead, the submission relies on the concept of Substantial Equivalence to legally marketed predicate devices.
Therefore, most of the requested information cannot be extracted from this document, specifically:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Here's what can be extracted, based on the provided text:
1. Acceptance Criteria and Reported Device Performance:
The document states:
- "Miltex Inc. will assure that product will be manufactured as indicated above and with the further confirmation that the Pins will meet all parameters of our print specifications and current ISO standards referenced under Performance Standards, Miltex Inc. then hereby claims that these Steinmann/Fixation Pins are Substantially Equivalent."
- "The above attestation therefore deems this product as being Safe and Effective. Our (5) plus years in which Miltex Inc. has already sold Steinmann/Fixation Pins in the Veterinary marketplace, serves as additional confirmation of the Safety and Effectiveness of this new product line. Miltex Quality records for these products support our claim."
There are no explicit quantitative acceptance criteria or reported device performance metrics in the provided text. The acceptance criteria are implicitly linked to manufacturing consistency, adherence to print specifications, and current ISO standards. Device performance is not quantitatively reported but is inferred from the substantial equivalence claim and prior use in veterinary medicine.
2. Study that proves the device meets the acceptance criteria:
The primary "proof" for regulatory clearance is based on the claim of Substantial Equivalence to legally marketed predicate devices, rather than a clinical study evaluating specific performance criteria against predefined acceptance thresholds.
The relevant statements are:
- "Miltex Inc. is claiming Substantial Equivalence for our Fixation Pins, Smooth and Threaded based upon the cross referenced information as presented in the Spread Sheet, pages 5-2 and 5-3, which clearly indicates a large representation of other manufacturers. Their similar products have been utilized in the medical device market for many years."
- "The subject Pins have already been assigned Product Codes of 87HTY and 87JDW by the FDA. The FDA in these classifications has already issued 510(k) numbers to manufacturers who sell and or distribute these product lines."
- "Our (5) plus years in which Miltex Inc. has already sold Steinmann/Fixation Pins in the Veterinary marketplace, serves as additional confirmation of the Safety and Effectiveness of this new product line. Miltex Quality records for these products support our claim."
Summary of available information:
| Category | Detail |
|---|---|
| Acceptance Criteria | Implicit: Adherence to print specifications, current ISO standards, and manufacturing consistency. No explicit quantitative performance metrics or thresholds are provided. |
| Device Performance | Not quantitatively reported. Performance is considered "Safe and Effective" based on substantial equivalence to predicate devices and 5+ years of use in the veterinary marketplace. |
| Sample size (test set) | Not applicable, as no specific performance study against acceptance criteria is described. The assessment is based on substantial equivalence and historical performance in veterinary use. |
| Data Provenance (test set) | Not applicable for a separate "test set" in the context of this submission. The claim relies on the long-standing use of similar products in the medical device market and Miltex's own veterinary sales history. |
| Number of Experts (ground truth) | Not applicable, as no ground truth establishment for a test set is described. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method | Not applicable. |
| MRMC Comparative Effectiveness | No. This is a claim of substantial equivalence for a physical medical device, not an AI-based system or a comparative effectiveness study with human readers. |
| Standalone Performance Study | No. The submission focuses on comparison to predicate devices and past veterinary use, not a standalone performance study with specific metrics. |
| Type of Ground Truth | Not explicitly defined as no specific study establishing ground truth for performance is presented. The "ground truth" for clearance is essentially the established safety and effectiveness of predicate devices and the device's own history in veterinary applications. |
| Sample size (training set) | Not applicable, as this is not an AI/machine learning device. |
| Ground truth for training set | Not applicable. |
{0}------------------------------------------------
MAY 0.1 2002
Page 6-1
:: +
K0k3888
page 1 of 2
[510(k)] Summary
Submitted by:
Miltex Inc. 700 Hicksville Road Bethpage, New York 11714 Tel: 516-349-0001
Contact:
Richard Gordon RA/QA Manager Tel: 516-576-6022 Fax: 516-576-8122
Richard Oslin
Signature
November 21, 2001
Date
Date
{1}------------------------------------------------
Page 6-2
[510(k)] Summary (Continued)
K013888
page 2 of 2
| Common/Trade Names: | Steinmann and Fixation Pins |
|---|---|
| Classification Names: | Pin, Fixation, SmoothPin, Fixation, Threaded |
| Substantial Equivalence | Miltex Inc. is claiming Substantial Equivalence |
Claim:
for our Fixation Pins, Smooth and Threaded based upon the cross referenced information as presented in the Spread Sheet, pages 5-2 and 5-3,
which clearly indicates a large representation of other manufacturers. Their similar products have been utilized in the medical device market for many years. In addition, the subject Pins have already been assigned Product Codes of 87HTY and 87JDW by the FDA. The FDA in these classifications has already issued 510(k) numbers to manufacturers who sell and or distribute these product lines.
The "Statement of Intended Use" adequately describes the product functions, concepts of use and device designs related to material used for manufacture. Certificates of Mill Analysis will be maintained in our Device History Records (DHR), as evidence of the 316LVM material used to produce these products.
Miltex Inc. will assure that product will be manufactured as indicated above and with the further confirmation that the Pins will meet all parameters of our print specifications and current ISO standards referenced under Performance Standards, Miltex Inc. then hereby claims that these Steinmann/Fixation Pins are Substantially Equivalent.
The above attestation therefore deems this product as being Safe and Effective. Our (5) plus years in which Miltex Inc. has already sold Steinmann/Fixation Pins in the Veterinary marketplace, serves as additional confirmation of the Safety and Effectiveness of this new product line. Miltex Quality records for these products support our claim.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
MAY 0-1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Gordon Regulatory Affairs/Quality Assurance Manager Miltex, Inc. 700 Hicksville Road Bethpage, NY 11714-3490
Re: K013888
Trade/Device Name: Pins, Fixation (Steinmann), Smooth and Threaded Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY, IDW Dated: February 27, 2002 Received: February 28, 2002
Dear Mr. Gordon:
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.
{3}------------------------------------------------
Page 2 - Mr. Richard Gordon
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 M. Mclhessor
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Miltex
Page 4-1
510(k) Number: K013888
Device Namc: Pins, Fixation (Steinmann), Smooth and Threaded
Indications for Use:
-
It is the intention of Miltex Inc. to introduce into the marketplace a line of Fixation/Steinmann Pins both Smooth and Threaded.
-
The material is 316LVM, Stainless Steel and the Pins are to be utilized for internal fixation of bone fractures.
-
The Pins are used specifically for fractures of the proximal or distal end of long bones such as intracapsular intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur.
-
The device(s) may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Mark N Milliman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013888
Image /page/4/Picture/13 description: The image shows a black and white logo or emblem. The logo is circular in shape and features stylized text at the top, which appears to read "Miller." Below the text, there is a large letter "M" in a bold, sans-serif font. The overall design is simple and compact, suggesting it may be a brand mark or identifier.
§ 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.