(21 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices.
Yes
The device is used for the "general management of fractures and reconstructive surgery," which are therapeutic applications.
No
The intended use describes the device as being used for the "general management of fractures and reconstructive surgery," which implies treatment rather than diagnosis. There is no mention of identifying, detecting, or characterizing a disease or condition.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the general management of fractures and reconstructive surgery." This describes a device used on a patient during a medical procedure, not a device used to test samples from a patient (which is the core function of an IVD).
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Any of the typical components or processes associated with IVDs (reagents, assays, sample preparation, etc.)
Therefore, based solely on the provided text, this device falls outside the definition of an In Vitro Diagnostic. It appears to be a surgical or orthopedic device used directly in patient care.
No
There is no mention of a Predetermined Change Control Plan (PCCP) within the provided clearance letter. For a device to be authorized under a PCCP, the clearance letter would explicitly state this, often detailing the types of changes covered and the associated update protocols.
Intended Use / Indications for Use
This device is used in the general management of fractures and reconstructive surgery.
Product codes
HWC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The overall design is simple and conveys the department's focus on health and human welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 200i
Triage Medical Inc. c/o Ms. Rita Giebel Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606
Re: K013903
Trade/Device Name: Helical Compression Anchor System, Cannulated, Version 2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 21, 2001 Received: November 26, 2001
Dear Ms. Giebel:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1978, ins cassordance with the provisions of the Federal Food, Drug, de noos mat hat o been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, increrere, mailes 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 rr your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a succeral 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 r toase of acrised alat i sermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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.
1
Page 2 - Ms. Rita Giebel
This letter will allow you to begin marketing your device as described in your fection 510(k) This letter will anow you is cegain mailing of substantial equivalence of your device to a legally premarket notification: "The PDF intelling of easification 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 IT you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CHC Fat 00710 Idditionally, for questions on the promotion and advertising of Compliance at (301) 591 1057. The may at (301) 594-4639. Also, please note the your do roo, produce combranding by reference to premarket notification" (21CFR Part 807.97). Tegulation entitled, "Misorananing of responsibilities under the Act may be obtained from the Other general information on your respectional 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,
f
Celia M. Witten, Ph.D., M.D.
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
Enclosure
2
Indications for Use Statement
Page 1 of 1
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K013903 |
Device Name: Helical Compression Anchor System, Cannulated, Version 2
Indications for Use:
This device is used in the general management of fractures and reconstructive surgery.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013903
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
REGULATORY SPECIALISTS
Pagc I l