(76 days)
This device is intended for local coagulation of soft tissues during minimally invasive orthopedic surgeries, such as, but not limited to hip, knee, shoulder and elbow arthroplasty by use of high-frequency electrical current. This local coagulation serves to mark the tissue to aid the surgeon in the location of subsequent osteotomies.
The Osteotomy Guide will be used as an aid to help the surgeon mark the periosteal location of the osteotomy cut in the calcar of the femur as part of a replacement surgery.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Zimmer Minimally Invasive Solutions™ Osteotomy Guide Instrument:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from UL Testing) | Reported Device Performance (from UL Testing) |
|---|---|
| Compliance with IEC 60601-1 (1988) second edition with Amendment No. 1 (1991) and No. 2 (1995) | Passed all applicable tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "test set" described is a non-clinical "UL Testing" of electrical safety standards. It does not involve a data set of patient cases.
- Data Provenance: Not applicable. The testing was non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth as typically understood for medical device studies (e.g., expert clinical review, pathology) was not established. The "ground truth" here is the pass/fail criteria of the specified electrical safety standards. The "experts" would be the certified laboratory personnel performing the UL testing.
4. Adjudication Method for the Test Set
- Not applicable. The UL testing involved objective measurements against established electrical safety standards, not subjective interpretation requiring adjudication among experts.
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 device is not an AI-powered diagnostic or interpretive tool; it is a surgical instrument for tissue coagulation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is a physical surgical instrument, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
- For the non-clinical performance, the "ground truth" was compliance with the specified electrical safety standard IEC 60601-1 (1988) second edition with Amendment No. 1 (1991) and No. 2 (1995).
- The document explicitly states: "Clinical data and conclusions were not needed for this device."
8. The Sample Size for the Training Set
- Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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KO33652 (pg 1 of 2
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Stephen H. McKelveyManager, Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605 |
| Date: | November 19, 2003 |
| Trade Name: | Minimally Invasive Solutions™ Osteotomy GuideInstrument |
| Common Name: | Osteotomy Guide |
| Classification Nameand Reference: | Electrosurgical Cutting and Coagulation Device andAccessories, 21 CFR § 878.4400 |
| Predicate Device: | Saphyre Bipolar Ablation Probes, manufactured bySmith and Nephew, Inc., K031371, cleared May 23,2003. |
| Device Description: | The Osteotomy Guide will be used as an aid to helpthe surgeon mark the periosteal location of theosteotomy cut in the calcar of the femur as part of areplacement surgery. |
| Intended Use: | This device is intended for local coagulation of softtissues during minimally invasive orthopedicsurgeries, such as, but not limited to hip, knee,shoulder and elbow arthroplasty by use of high-frequency electrical current. This local coagulationserves to mark the tissue to aid the surgeon in thelocation of subsequent osteotomies. |
| Comparison to Predicate Device: | Both the predicate and proposed device are used tocoagulate soft tissue. |
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Traditional 510(k) Premarket Notification
K033652 (pg 2 of 2)
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
UL Testing was performed per IEC 60601-1 (1988) second edition with Amendment No. 1 (1991) and No. 2 (1995) and passed all applicable tests.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K033652
Trade/Device Name: Minimally Invasive Solutions™ Osteotomy Guide Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 19, 2003 Received: November 20, 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 commercc 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
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 - Mr. Stephen H. McKelvey
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.
Miriam C. Provost
les
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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Indications for Use
KO33652 510(k) Number (if known):
Device Name:
Minimally Invasive Solutions™ Osteotomy Guide Instrument
Indications for Use:
This device is intended for local coagulation of soft tissues during minimally invasive orthopedic surgeries, such as, but not limited to hip, knee, shoulder and elbow arthroplasty by use of high-frequency electrical current. This local coagulation serves to mark the tissue to aid the surgeon in the location of subsequent osteotomies.
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)
Ko 33652
iriam C. Provost
Jusion Sign-Off) reision of General, Restorative . | Neurologi ******************************************************************************************************************************************************************************
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.