(157 days)
Not Found
No
The device description explicitly states it is a "manually operated instrument" and the performance studies focus on mechanical properties like cut testing, foot load plate testing, cycle testing, and corrosion resistance. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No
The device is a surgical instrument for cutting bony tissue. While used in a medical context, it is not used to treat or cure a disease or condition, which is characteristic of therapeutic devices.
No
This device is a surgical instrument used for cutting bony tissue, not for diagnosing medical conditions.
No
The device description clearly states it is a manually operated instrument with a reusable handle and disposable tips made of stainless steel, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Symmetry Kerrison Disposable Tip Rongeurs are described as manually operated instruments used for cutting bony tissue of the spine. This is a surgical procedure performed directly on the patient's body, not an examination of a specimen outside the body.
The information provided clearly indicates this is a surgical instrument, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue of the spine.
Product codes
HAE
Device Description
The Symmetry Kerrison Disposable Tip Rongeurs are manually operated instruments, provided with a non-sterile reusable handle and a set of sterile, disposable tips, indicated for cutting bony tissue of the spine. They represent a design modification to the predicate devices, the Codman Kerrison Laminectomy Rongeurs and the Integra Kerrison Rongeurs, introducing disposable tips to the device.
The Symmetry Kerrison Disposable Tip Rongeurs handles are comprised of stainless steel, and operate with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The handles and disposable tips are provided in various sizes to help provide the surgeons with more options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance testing consisting of cut testing, foot load plate testing, cycle testing and corrosion resistance demonstrates the proposed devices perform according to its description and intended use and supports the safety and effectiveness of the device. The Symmetry Surgical Disposable Tip Rongeurs conform to their design specifications and are substantially equivalent to the commercially distributed devices for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Codman Kerrison Laminectomy Rongeurs, K092227
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).
0
K130541
510(k) Summary of Safety and Effectiveness
(Per 21 CFR 807.92)
General Company Information
| Company Name: | Symmetry Surgical | |
|---|---|---|
| Company Address: | 3034 Owen Drive | |
| Nashville, TN 37013 | AUG 0 5 2013 | |
| Company Telephone: | 615-964-5558 | |
| Contact: | Dalene T. Binkley, MS, RAC | |
| Contact Address | ||
| and Telephone: | 1927 N. Arthur Drive | |
| Columbia City, IN 46725 | ||
| 260-244-4189 | ||
| Date: | February 24, 2013 | |
| Device Trade Name: | Symmetry Kerrison Disposable Tip Rongeurs | |
| Common Name: | Manual Rongeurs | |
| Classification Name | ||
| and Reference: | HAE - Class II (21 CFR 882.4840) | |
| Predicate Device: | Codman Kerrison Laminectomy Rongeurs, | |
| Preamendment | ||
| Integra Kerrison Rongeurs, K092227, cleared 2/17/1 |
1
Device Description: The Symmetry Kerrison Disposable Tip Rongeurs are manually operated instruments, provided with a non-sterile reusable handle and a set of sterile, disposable tips, indicated for cutting bony tissue of the spine. They represent a design modification to the predicate devices, the Codman Kerrison Laminectomy Rongeurs and the Integra Kerrison Rongeurs, introducing disposable tips to the device.
The Symmetry Kerrison Disposable Tip Rongeurs handles are comprised of stainless steel, and operate with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The handles and disposable tips are provided in various sizes to help provide the surgeons with more options.
Intended Use: The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue in the area of the spine. This intended use is similar to that of our predicate devices.
Technological Characteristics: The technological characteristics of the proposed device are similar or the same as those of the predicate devices. The design modification introduces disposable tips to the device providing the surgeon with a disposable option while assuring the sterility and sharpness of the tips. This design modification does not impact the safety and effectiveness of the device. The Symmetry Kerrison Disposable Tip Rongeurs are substantially equivalent to their predicate devices Codman Kerrison Laminectomy Rongeurs and Integra Kerrison Rongeurs. Substantial equivalence is based on intended use, performance characteristics, materials, and principle of operation.
Performance Data (Nonclinical and/or Clinical): Performance testing consisting of cut testing, foot load plate testing, cycle testing and corrosion resistance demonstrates the proposed devices perform according to its description and intended use and supports the safety and effectiveness of the device. The Symmetry Surgical Disposable Tip Rongeurs conform to their design specifications and are substantially equivalent to the commercially distributed devices for the same intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The seal is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 5, 2013
Symmetry Surgical % Dalene T. Binkley, MS, RAC Regulatory Affairs Consultant 1927 N. Arthur Drive Columbia City, IN 46725
Re: K130541
Trade/Device Name: Symmetry Kerrison Disposable Tip Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: June 18, 2013 Received: June 25, 2013
Dear Ms. Binkley:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal 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); medical device reporting
3
Page 2 - Ms. Dalene T. Binkley
(reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K130541
Device Name: Symmetry Kerrison Disposable Tip Rongeurs
Indications For Use:
The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue of the spine.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ___________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang -S
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K130541
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