(66 days)
Sirus intramedullary nail for femur with cap screw and corresponding locking screws:
- All compound and simple femoral shaft fractures
- Sub-trochanteric fractures
- Pseudarthrosis and delayed union
Sirus intramedullary nail for femur in combination with the Sirus cervical screws: - Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures
Sirus intramedullary nail for tibia with cap screw and corresponding locking screws: - Simple, compound first- and second-degree tibial shaft fractures
- Pseudarthrosis and delayed union
The Sirus Intramedullary Nails are manufactured from titanium alloy, and are available in a variety of lengths and diameters. They are intended for insertion into the medullary canal of the femur or tibia for the fixation of fractures.
The provided document is a 510(k) premarket notification for the "Sirus™ Intramedullary Nail" (K043270). It discusses the device description, intended use, and comparison to predicate devices. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria, specific study designs, sample sizes for test/training sets, expert qualifications, or ground truth establishment.
The document states: "The results of non-clinical analysis demonstrate that the device is safe and effective and substantially equivalent to the predicate device(s)." This indicates that non-clinical testing was performed to show substantial equivalence. However, the exact acceptance criteria, the specific studies performed, and their results are not detailed in this summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "The results of non-clinical analysis demonstrate that the device is safe and effective and substantially equivalent to the predicate device(s)." |
Missing Information: The document does not specify quantitative acceptance criteria (e.g., specific thresholds for strength, fatigue, or other biomechanical properties). It only broadly states that non-clinical analysis demonstrated safety, effectiveness, and substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document mentions "non-clinical analysis" but does not provide any details about the sample sizes used for testing, the type of data (e.g., material testing, biomechanical testing), or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: This information is not applicable and not provided. The study mentioned is "non-clinical analysis," which typically refers to mechanical or material testing, not studies involving human experts or ground truth in the context of diagnostic or treatment performance with patients.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: This information is not applicable and not provided. As mentioned above, the study is non-clinical.
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
Missing Information: This information is not applicable and not provided. The device is an intramedullary nail, which is a physical implant for fracture fixation, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Missing Information: This information is not applicable and not provided. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Missing Information: This information is not applicable and not provided. The "non-clinical analysis" would involve engineering and material property measurements, not clinical ground truth.
8. The sample size for the training set
Missing Information: The document mentions "non-clinical analysis," but it does not describe any training sets, which are typically associated with machine learning or AI models. Given that this is a physical medical device, training sets in that context are not relevant.
9. How the ground truth for the training set was established
Missing Information: This information is not applicable and not provided, for the same reasons as point 8.
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093270
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Image /page/0/Picture/1 description: The image shows the letters 'f' and 'z' in a handwritten style. The letters are connected, with the 'f' appearing first and the 'z' following it. The handwriting is simple and clear, making the letters easily recognizable.
Image /page/0/Picture/2 description: The image contains the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a bold, sans-serif font. The letter "Z" is black, while the circle is white with a black outline, and the word "zimmer" is also black.
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Laura D. Williams, RACManager, Regulatory AffairsTelephone: (574) 372-4523Fax: (574) 372-4605 |
| Date: | November 24, 2004 |
| Trade Name: | Sirus ® Intramedullary Nail |
| Classification Nameand Reference: | Intramedullary Fixation Rod21 CFR § 888.3020 |
| Predicate Devices: | Unreamed Tibial Nail, manufactured by Synthes,K932330, cleared 03/08/1996Lateral Entry Femoral Nail System by Synthes,K040336, cleared 04/12/2004Osteo IC Retrograde/Antegrade Femoral Nail,manufactured by Osteonics, K982601, cleared09/14/1998T2 Femoral Nail System, manufactured byHowmedica Osteonics, K010801, K014220, andK021744; cleared 04/06/2001, 01/25/2002, and06/26/2002, respectively |
| Device Description: | The Sirus Intramedullary Nails are manufacturedfrom titanium alloy, and are available in a variety oflengths and diameters. They are intended forinsertion into the medullary canal of the femur ortibia for the fixation of fractures. |
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| Intended Use: | Sirus intramedullary nail for femur with capscrew and corresponding locking screws: |
|---|---|
| • All compound and simple femoral shaft fractures | |
| • Sub-trochanteric fractures | |
| • Pseudarthrosis and delayed union | |
| Sirus intramedullary nail for femur incombination with the Sirus cervical screws: | |
| • Shaft fractures in combination with femoral neckfractures or peritrochanteric fractures | |
| Sirus intramedullary nail for tibia with capscrew and corresponding locking screws: | |
| • Simple, compound first- and second-degree tibialshaft fractures | |
| • Pseudarthrosis and delayed union | |
| Comparison to Predicate Device: | The Sirus Intramedullary Nail has the sameintended use, has similar performancecharacteristics, is manufactured from similarmaterials using similar processes, and is similar indesign to the predicate devices. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions: |
| The results of non-clinical analysis demonstrate thatthe device is safe and effective and substantiallyequivalent to the predicate device(s). |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and converge, resembling a human figure or a stylized representation of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2005
Zimmer GMBH C/o Zimmer, Inc Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 465810
Re: K043270
Trade/Device Name: Sirus™ Intramedullary Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 24, 2004 Received: November 26, 2004
Dear Ms. Williams:
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.
Picase 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 fisting (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. Laura D. Williams, 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) 276-0210. 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/industry/support/index.html.
Sincerely yours,
A. Mark A. Millkens
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
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K64 3270 141
Indications for Use
510(k) Number (if known):
Device Name:
Sirus™ Intramedullary Nail
Indications for Use:
Sirus intramedullary nail for femur with cap screw and corresponding locking screws
- · All compound and simple femoral shaft fractures
- · Sub-trochanteric fractures
- · Pseudarthrosis and delayed union
Sirus intramedullary nail for femur in combination with the Sirus cervical screws
- · Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures
Sirus intramedullary nail for tibia with cap screw and corresponding locking screws
- · Simple, compound first- and second-degree tibial shaft fractures
- · Pseudarthrosis and delayed union
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Resative,
and Neurological Devices
$10(k) Number
Page 1 of 1
§ 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.