(57 days)
Not Found
No
The device description and intended use clearly define a manual surgical instrument (rongeur) used for cutting bone and tissue. There is no mention of any computational or data-driven components, let alone AI or ML. The performance studies focus on design analysis and comparison to predicate devices, not on algorithmic performance.
No.
The device is a surgical instrument (rongeur) used for cutting and biting tissue and bone during surgery, not for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device description clearly states its use is for "cutting and biting soft tissue and bone during surgery involving the spinal column," and "for gouging out bone and tissue." These are surgical, not diagnostic, functions.
No
The device description clearly describes a physical, manually operated surgical instrument (a rongeur) used for cutting bone and tissue. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "access, cut and bite soft tissue and bone during surgery involving the spinal column." This describes a surgical instrument used in vivo (within the body) for physical manipulation of tissue and bone.
- Device Description: The description reinforces that it's a surgical instrument used for cutting, biting, and gouging bone and tissue during surgical procedures like laminectomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health, diagnose a condition, or monitor treatment.
In Vitro Diagnostic devices are specifically designed to perform tests on samples taken from the human body. This device is clearly a surgical tool used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The intended use of Instrumed Rongeurs is to access, cut and bite soft tissue and bone during surgery involving the spinal column.
Product codes
HAE
Device Description
A rongeur (Kerrison) is a strongly constructed instrument with a sharp-edged, scoop-shaped tip, used during laminectomy for gouging out bone and tissue.
IVD (Intervertebral Disc) Rongeurs are used on cartilage that separates adjacent vertebrae of the spine A rongeur can be used to open a window in a bone. It is used in neurosurgery to expose areas for operation or to reduce pressure by segregating exposed areas.
To ensure the multi-purpose use of this devices, many different models are available.
Common names used for this kind of Rongeurs are: Kerrison, Sella Punch, IVD (Decker, MIS, Spence, Peapod, Selverstone, Williams, Cushing, Love-Gruenwald, Spurling, Cloward, Sypert, Ferris-Smith, Wilde, Hoen, Oldberg, Jackson, Schlesinger)
A manual rongeur is a manually operated instrument used for cutting or biting surgery involving the skull or spinal column.
All Rongeurs are offered in a non-sterile condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal column
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the P.D. cited and raise no new issues of safety and effectiveness
The Instrumed Rongeur is similiar to the P.D. in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characterisits as well as sizes and configurations. Therefore it can be deemed substantially equivalent and safe and effective for its indicated use.
The presented data that was conducted on the Instrumed Rongeurs shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not ralse any new questions regarding safety and effectiveness. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Ko81651
510(k) Summary as required by section 807.92(c)
date prepared 06/02/2008
Submission Applicant:
INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
Establishment Registration Number:
1421101
Official Correspondent:
Mr. Berndt Fetzer INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
Phone: 847-908-0292
Trade name:
Instrumed Rongeur
Common name:
Rongeur
Classification name:
RONGEUR, MANUAL (21 CFR 882.4840, Product code HAE)
Regulation Description
Manual rongeur.
A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.
Substantial Equivalence Claim:
| K062711; | Baxano; | Ultra Low profile Rongeur |
|---|---|---|
| K023868; | Dannoritzer Medical Instruments; | Dan Kerrison Rongeurs, Models K1 & BILLY |
| K943635; | CARDINAL HEALTH(V.MUELLER) Rongeurs | |
| K-MEDIC/TELEFLEX; | IVD Rongeurs and Spinal Punches | |
| And many other Rongeurs marketed, some under the pre-amendment assessment rule |
1
Description of the Device:
A rongeur (Kerrison) is a strongly constructed instrument with a sharp-edged, scoop-shaped tip, used during laminectomy for gouging out bone and tissue.
IVD (Intervertebral Disc) Rongeurs are used on cartilage that separates adjacent vertebrae of the spine A rongeur can be used to open a window in a bone. It is used in neurosurgery to expose areas for operation or to reduce pressure by segregating exposed areas.
To ensure the multi-purpose use of this devices, many different models are available.
Common names used for this kind of Rongeurs are: Kerrison, Sella Punch, IVD (Decker, MIS, Spence, Peapod, Selverstone, Williams, Cushing, Love-Gruenwald, Spurling, Cloward, Sypert, Ferris-Smith, Wilde, Hoen, Oldberg, Jackson, Schlesinger)
Device description / Identification
A manual rongeur is a manually operated instrument used for cutting or biting surgery involving the skull or spinal column.
All Rongeurs are offered in a non-sterile condition.
Indications for Use:
The intended use of Instrumed Rongeurs is to access, cut and bite soft tissue and bone during surgery involving the spinal column.
Performance Data
Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the P.D. cited and raise no new issues of safety and effectiveness
Comparison with P.D.
The Instrumed Rongeur is similiar to the P.D. in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characterisits as well as sizes and configurations. Therefore it can be deemed substantially equivalent and safe and effective for its indicated use.
Summary
. . .
The presented data that was conducted on the Instrumed Rongeurs shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not ralse any new questions regarding safety and effectiveness. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The seal is a symbol of the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2008
Instrumed International, Inc. % Mr. Michael Massong RA/QA Director 626 Cooper Court Schaumburg, Illinois 60173
Re: K081651
Trade/Device Name: Instrumed Ronguer Regulation Number: 21 CFR 882.4840 Regulation Name: Manual ronguer Regulatory Class: II Product Code: HAE Dated: June 2, 2008 Received: June 12, 2008
Dear Mr. Massong:
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 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. Michael Massong
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 长081651
Device Name:
Instrumed Rongeur
Indications For Use:
The intended use of Instrumed Rongeur is to access, cut and bite soft tissue and bone during surgery involving the spinal column.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
R.N.
ision Sign-Off) (Div Division of General, Restorative, and Neurological Devices
510(k) Number L081651