(23 days)
The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
This Special 510(k) submission is a line extension to address modifications to the Asnis™ III Cannulated Screw System. This line extension is to add additional sizes of screws to the system.
The provided text describes a Special 510(k) submission for a line extension of the Asnis™ III Cannulated Screw System, specifically to add additional sizes of screws. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than conducting extensive new clinical studies with established acceptance criteria as would be typical for novel devices.
Therefore, many of the standard elements you've requested regarding acceptance criteria and detailed study information are not applicable in this context. The primary "study" performed here is mechanical testing to prove the new screw sizes are as strong as the predicate devices.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strength of new screw sizes is substantially equivalent to predicate systems. | Mechanical testing demonstrated that the subject components are substantially equivalent in strength to the predicate components. |
Explanation: For a 510(k) submission, especially a line extension like this, the "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence. The key performance metric is the mechanical strength of the new screw sizes compared to the legally marketed predicate devices. The submission asserts that this equivalence was met through mechanical testing. Specific numerical thresholds for "strength" are not provided in this summary but would have been part of the underlying test reports submitted to the FDA.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided summary. Mechanical testing typically involves a set number of samples for each size and material tested, but the exact count isn't given here.
- Data Provenance: Not explicitly stated, but mechanical testing is usually performed in a laboratory setting by the manufacturer or a contracted testing facility. Given the manufacturer (Howmedica Osteonics Corp.) is based in Mahwah, New Jersey, USA, the testing likely occurred in the US. The data is prospective in the sense that it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. For mechanical testing of this nature, "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists, pathologists) are not involved. The ground truth is established by standardized mechanical testing protocols and measurements, typically interpreted by engineering and quality control professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for clinical reads (e.g., imaging studies) where human interpretation is involved. This submission focuses on objective mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a mechanical device, not an AI or imaging device. Therefore, MRMC studies and concepts of human reader improvement with AI are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A (for clinical ground truth). The "ground truth" in this context is the objective measurement of mechanical properties (e.g., strength, stiffness) as defined by engineering standards and specifications. The performance of the new devices is compared against the measured performance of the predicate devices.
8. The sample size for the training set
- N/A. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- N/A. There is no "training set" and thus no ground truth for it to be established.
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K071092 1/1
Summary of Safety and Effectiveness Asnis™ III Cannulated Screw System Line Extension
MAY 1 1 2007
| Proprietary Name: | Asnis™ Micro Cannulated Screw |
|---|---|
| Common Name: | Bone Screw |
| Classification Name and Reference: | Smooth or Threaded Metallic BoneFixation Fastener, 21 CFR §888.3040 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 HWC: Screw, Fixation, Bone |
| For Information contact: | Vivian Kelly, Sr. Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038 |
| Date Summary Prepared: | April 17, 2007 |
Description:
This Special 510(k) submission is a line extension to address modifications to the Asnis™ III Cannulated Screw System. This line extension is to add additional sizes of screws to the system.
Intended Use
The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject device are provided below.
Indications
The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Substantial Equivalence:
These additional components are substantially equivalent to their predicate systems in respect to design, intended use, performance and operational principle as internal fixation components. Predicate systems include the Asnis™ III Cannulated Screw System (K000080 and K024060) and other commercially available cannulated screws on the market such Vilex 2mm Screws (K973309, K991151 & K991197) and Synthes Cannulated Screws (K962823.) Mechanical testing was conducted to compare the strength of the subject device to predicate screws. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 2007
Howmedica Osteonics Corporation % Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K071092
Trade/Device Name: Asnis™ III Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth of threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 17, 2007 Received: April 18, 2007
Dear Ms. Kelly:
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.
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Page 2 - Ms. Vivian Kelly, RAC
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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Obarbare Bruckner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Asnis™ III Cannulated Screw System
Indications for Use:
The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K071092 |
|---|---|
| --------------- | --------- |
§ 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.