(23 days)
No
The 510(k) summary describes a line extension for a screw system, adding new sizes. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on mechanical strength, not algorithmic performance.
No
The device is intended for "fracture fixation," which is a treatment for injuries, but not broadly considered a 'therapeutic device' in the sense of delivering therapy. It is an osteosynthesis device, a type of medical implant used to stabilize bone fractures.
No
The device is a screw system used for fracture fixation, meaning it is a therapeutic device for treatment, not a diagnostic device for identifying medical conditions.
No
The device description clearly states it is a "Cannulated Screw System" and describes adding "additional sizes of screws," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of small and long bones and of the pelvis." This describes a surgical implant used to stabilize broken bones within the body.
- Device Description: The device is a "Cannulated Screw System" and the modification is adding "additional sizes of screws." This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples. This device is used in vivo (in the body) for structural support.
N/A
Intended Use / 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.
Product codes
87 HWC
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones and of the pelvis.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K973309, K991151, K991197, K962823
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Bone |
| Fixation 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 Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 | |
| Fax: (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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged on a single line, with 'Public' and 'Health' being slightly larger than 'Service'. The text is likely a heading or label, possibly indicating the source or subject of a document or presentation.
Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three overlapping wings, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
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.
2
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
3
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)
| Page 1 of 1 | Concurrence of CDRH, Office of Device Evaluation (ODE) | 33 |
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| ------------- | -------------------------------------------------------- | ---- |
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K071092 |
|---|---|
| --------------- | --------- |