(96 days)
Not Found
No
The description focuses on the mechanical and pneumatic operation of the device, with no mention of AI, ML, or related concepts.
No
The device is described as a surgical tool for removing bone, cartilage, and tissue, which is an interventional/surgical function, not a therapeutic one.
No
The device is described as surgical instrumentation intended for removing bone, cartilage and tissue, indicating its therapeutic rather than diagnostic function. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly indicates it is a physical, pneumatically powered surgical instrument for removing bone, cartilage, and tissue. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "removing bone, cartilage and tissue in various surgical disciplines". This describes a surgical instrument used on the patient during a procedure, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details a pneumatically powered surgical tool with a punching action. This aligns with a surgical instrument, not an IVD device which typically involves analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the Aesculap Pneumatic Kerrison is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Aesculap's Pneumatic Kerrison is intended for removing bone, cartilage and tissue in various surgical disciplines (e.g. neurosurgery and othopaedics).
Product codes
HAD
Device Description
The Aesculap Pneumatic Kerrison is powered by pneumatic pressure. The power is supplied by compressed air through luer lock connectors. The compressed air is then transferred into the working direction via an angle lever. The movable sheath pusher moves forward and the punching action is carried out in a two step process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, cartilage and tissue
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)
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. This device has been evaluated and complies with ASTM F899-95, Standard Specification for Stainless Steel for Surgical Instruments as applicable.
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
§ 882.4845 Powered rongeur.
(a)
Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).
0
Pneumatic Kerrision
Page 1 of 2
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap Pneumatic Kerrison August 16, 2006
Nije 2 1 2006 Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 CONTACT: Kathy A. Racosky 800-258-1946 (phone) 610-791-6882 (fax) kathv.racosky@aesculap.com COMMON NAME: Powered rongeur CLASSIFICATION NAME: Rongeur, Powered REGULATION NUMBER: 882.4845 PRODUCT CODE: HAD
SUBSTANTIAL EQUIVALENCE
Aesculap®. Inc. believes that the Pneumatic Kerrison is substantially equivalent to:
- Aesculap Hilan Motor System by Aesculap Inc. (K980686) .
- Aesculap manual Kerrisons by Aesculap Inc. (Class I device) .
- Anspach Powered Kerrison System (PKS) by The Anspach Effort, Inc . (K022907)
DEVICE DESCRIPTION
The Aesculap Pneumatic Kerrison is powered by pneumatic pressure. The power is supplied by compressed air through luer lock connectors. The compressed air is then transferred into the working direction via an angle lever. The movable sheath pusher moves forward and the punching action is carried out in a two step process.
INDICATIONS FOR USE
Aesculap's Pneumatic Kerrison is intended for removing bone, cartilage and tissue in various surqical disciplines (e.g. neurosurgery and othopaedics).
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))
The Aesculap Pneumatic Kerrisons are offered in similar operating speeds, power source, and attachments as the predicate devices. The material used for the Aesculap Pneumatic Kerrison is the same or similar as that used to manufacture the predicate devices.
1 of 2
1
Page 2 of 2
PERFORMANCE DATA
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. This device has been evaluated and complies with ASTM F899-95, Standard Specification for Stainless Steel for Surgical Instruments as applicable.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Associatc 3773 Corporate Parkway Center Valley, Pennsylvania 18034
NOV 2 1 2006
Re: K062413
Trade/Device Name: Pneumatic Kerrison Regulation Number: 21 CFR 882.4845 Regulation Name: Powered rongeur Regulatory Class: II Product Code: HAD Dated: October 16, 2006 Received: October 17, 2006
Dear Ms. Racosky:
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.
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
3
Page 2 - Ms. Kathy A. Racosky
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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation -Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number: K062413
Device Name:
Indications for Use:
Aesculap's Pneumatic Kerrison is intended for removing bone, cartilage and tissue in various surgical disciplines (e.g. neurosurgery and othopaedics).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) No