(76 days)
Not Found
No
The summary describes a device for tissue coagulation using electrical current and does not mention any AI or ML related terms, image processing, or data analysis that would suggest the use of such technologies.
No
The device is used for local coagulation to mark tissue for subsequent osteotomies, not to treat a disease or condition. The function described is a surgical aid for marking, not a therapeutic intervention.
No
The device is used for local coagulation to mark tissue during surgery, not to diagnose a condition. Its function is to aid the surgeon in locating subsequent osteotomies.
No
The device description explicitly states it uses "high-frequency electrical current" for local coagulation, which requires hardware components beyond just software. The performance studies also mention UL testing per IEC 60601-1, a standard for medical electrical equipment, further indicating the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "local coagulation of soft tissues during minimally invasive orthopedic surgeries" to "mark the tissue to aid the surgeon in the location of subsequent osteotomies." This is a surgical tool used in vivo (within the living body) for a procedural purpose.
- Device Description: The description reinforces its use as an aid to "mark the periosteal location of the osteotomy cut." This is a physical marking process during surgery.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such diagnostic analysis on biological samples.
The device is clearly described as a surgical instrument used during an orthopedic procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues during minimally invasive orthopedic surgeries, such as, but not limited to hip, knee, shoulder and elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the word "zimmer" with a stylized "Z" in a circle to the left of the word. The "Z" is black and bolded, while the rest of the word is in a smaller, sans-serif font. The word "zimmer" is also bolded and black.
KO33652 (pg 1 of 2
Summary of Safety and Effectiveness
| 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: | November 19, 2003 |
| Trade Name: | Minimally Invasive Solutions™ Osteotomy Guide
Instrument |
| Common Name: | Osteotomy Guide |
| Classification Name
and Reference: | Electrosurgical Cutting and Coagulation Device and
Accessories, 21 CFR § 878.4400 |
| Predicate Device: | Saphyre Bipolar Ablation Probes, manufactured by
Smith and Nephew, Inc., K031371, cleared May 23,
2003. |
| Device Description: | 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. |
| Intended 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. |
| Comparison to Predicate Device: | Both the predicate and proposed device are used to
coagulate soft tissue. |
1
Image /page/1/Picture/0 description: The image contains the word "zimmer" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized "Z" inside. The logo and the word "zimmer" are both in black, contrasting with the white background.
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, composed of three curved lines. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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.
3
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
4
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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