(11 days)
Not Found
No
The summary describes a mechanical intramedullary nail for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for internal fracture fixation, which is a therapeutic intervention for femoral fractures.
No
The device is described as an intramedullary nail used for reduction and internal fracture fixation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an "intramedullary nail," which is a physical implant used for fracture fixation, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the internal fixation of femoral fractures. This is a surgical procedure performed on the patient's body.
- Device Description: The description details a physical implant (intramedullary nail) used to stabilize bone fractures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis.
The information provided describes a surgical implant used for orthopedic procedures, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:
- Subtrochanteric Fractures .
- Intertrochanteric Fractures .
- Comminuted Fractures ●
- Segmental Fractures ●
- Fractures with Bone Loss .
- Proximal and Distal Fractures .
- Nonunions ●
Product codes
HSB
Device Description
The ITST is used to provide reduction and internal fracture fixation of the femoral head and neck and has an intramedullary nail that is curved and tapered anatomically to accommodate the curvature of the intramedullary canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head and neck, intramedullary canal
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
Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the word "zımmer" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized letter "Z" inside. The letter "Z" is also in a bold, sans-serif font and is black, while the circle is white with a black outline.
Summary of Safety and Effectiveness
32367
page 1 of 2
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey
Manager, Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 372-4605 |
| Date: | July 31, 2003 |
| Trade Name: | ITST ™ Intertrochanteric Subtrochanteric
Intramedullary Femoral Nail |
| Common Name: | Intramedullary Nail |
| Classification Name
and Reference: | Intramedullary Fixation Rod
21 CFR § 888.3020 |
| Predicate Device: | M/DN Intramedullary Fixation System,
manufactured by Zimmer, K965098, cleared
February 28, 1997. |
| Device Description: | The ITST is used to provide reduction and internal
fracture fixation of the femoral head and neck and
has an intramedullary nail that is curved and tapered
anatomically to accommodate the curvature of the
intramedullary canal. |
| Intended Use: | The ITST Intramedullary Nail is indicated for use in
a variety of femoral fractures, such as:
• Subtrochanteric Fractures
• Intertrochanteric Fractures
• Comminuted Fractures
• Segmental Fractures
• Fractures with Bone Loss
• Proximal and Distal Fractures
• Nonunions |
·
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter 'Z' inside of a circle, followed by the word 'zimmer' in a smaller, bold font. The logo is black and white.
Comparison to Predicate Device:
Except for modifications to facilitate easier insertion, accommodate a larger lag screw and the addition of sliding and locking nail caps, ITST components are identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. The device is packaged and sterilized using the same materials and processes.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or stripes, possibly representing a flag or a symbol of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2003
Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Re: K032367
Trade/Device Name: ITST Intertrochanteric Subtrochanteric Intramedullary Femoral Nail Regulation Numbers: 21 CFR 888.3020 Regulation Names: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: July 31, 2003 Received: August 1, 2003
Dear Mr. McKelvey:
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
3
Page 2 - Mr. Stephen H. McKelvey
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), please contact the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Ulan Witt
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
4
Indications for Use
KO 32367
Page I of I
510(k) Number (if known):
Device Name:
ITST" Intertrochanteric Subtrochanteric Intramedullary Femoral Nail
Indications for Use:
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:
- Subtrochanteric Fractures .
- Intertrochanteric Fractures .
- Comminuted Fractures ●
- Segmental Fractures ●
- Fractures with Bone Loss .
- Proximal and Distal Fractures .
- Nonunions ●
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number_k032367
OR
Prescription Use
(Per 21 CFR 801.109)
$\checkmark$
Over-The-Counter Use (Optional Format 1-2-96)