(209 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of a manually operated surgical instrument. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is a surgical instrument for cutting bone, not for treating a disease or condition.
No
The device is described as a surgical instrument for cutting or biting bone, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device is a manually operated surgical instrument made of stainless steel, clearly indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cutting or biting bone during surgery involving the skull or spinal column." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "manually operated instrument" for surgical use.
- 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. This device does not interact with specimens in vitro.
The device is a surgical instrument used in vivo (within the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.
Product codes (comma separated list FDA assigned to the subject device)
HAE
Device Description
The SQ.line KERRISON bone punches are reusable surgical instruments made out of stainless are coated with Medthin™ 42 DLC. The bone punches are available with the following features: shaft lengths 180 - 280 mm, bite sizes 1 - 6 mm, jaw openings 10 - 15 mm, cutting angles 90° and 130° up/down, standard and thin profile footplates and semi-detachable or fully detachable with an ejector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull or 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)
A cutting test was performed to evaluate the cutting of the SQ.line KERRISON after 25,000 cuttings performed. The test performed confirmed the acceptance criterias were met.
A performance test was done in order to evaluate the force needed on the SQ.line KERRION to cut. The test performed showed that the applied force meets the acceptance criteria.
The mechanical performance was assessed after reprocessing and met the acceptance criteria.
Biocompatibility: Biocompatibility endpoints were evaluated in accordance with ISO 10993. Biocompatibility testing for chemical characterization of leachables/extractables, cytotoxicity, sensitization, irritation and acute systemic toxicity. Test results indicate that the SQ.line KERRISONS are biocompatible.
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
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
June 29, 2023
Aesculap, Inc. Benjamin Oswald Global Regulatory Affairs 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K223596
Trade/Device Name: SQ.line KERRISON Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: June 1, 2023 Received: June 1, 2023
Dear Benjamin Oswald:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature includes the name "Adam D. Pierce -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Adam D. Pierce -S" and "Date: 2023.06.29 17:23:17-04'00'".
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
SQ.line KERRISON
Indications for Use (Describe)
The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary 510(k) #: K223596 Prepared on: 2023-06-01 Contact Details 21 CFR 807.92(a)(1) Aesculap, Inc. Applicant Name Applicant Address 3773 Corporate Parkway Center Valley PA 18034 United States +4974619531061 Applicant Contact Telephone Mr. Benjamin Oswald Applicant Contact Applicant Contact Email benjamin.oswald@aesculap.de Device Name 21 CFR 807.92(a)(2) SQ.line KERRISON Device Trade Name Common Name Manual rongeur Rongeur, Manual Classification Name 882.4840 Requlation Number Product Code HAE Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K153243 Fehling Punches HAE Device Description Summary 21 CFR 807 92(a)(4) The SQ.line KERRISON bone punches are reusable surgical instruments made out of stainless are coated with Medthin™ 42 DLC. The bone punches are available with the following features: shaft lengths 180 - 280 mm, bite sizes 1 - 6 mm, jaw openings 10 - 15 mm, cutting angles 90° and 130° up/down, standard and thin profile footplates and semi-detachable or fully detachable with an ejector. Intended Use/Indications for Use 21 CFR 807.92(a)(5) The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column. Indications for Use Comparison 21 CFR 807.92(a)(5) The SQ.line KERRISON bone punches have the same indication for use as the predicate Fehling Punches.
Technological Comparison
The SQ.line KERRISON bone punches are substantially equivalent to the predicate Fehling Punches. The subject device intended use, design and principle of operation are the same as of the SQ.line KERRISON bone punches are manufactured from similar materials as the predicate devices.
21 CFR 807.92(a)(6)
4
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
A cutting test was performed to evaluate the cutting of the SQ.line KERRISON after 25,000 cuttings performed. The test performed confirmed the acceptance criterias were met.
A performance test was done in order to evaluate the force needed on the SQ.line KERRION to cut. The test performed showed that the applied force meets the acceptance criteria.
The mechanical performance was assessed after reprocessing and met the acceptance criteria.
Biocompatibility:
Biocompatibility endpoints were evaluated in accordance with ISO 10993. Biocompatibility testing for chemical characterization of leachables/extractables, cytotoxicity, sensitization,
irritation and acute systemic toxicity. Test results indicate that the SQ.line KERRISONS are biocompatible.
Animal and Clinical Testing:
No animal or clinical testing was necessary for determination of substantial equivalence.
Clinical testing is not applicable.
Both performance tests show that the SQ.line KERRISON periorms substantially equivalent to the predicate device and do not raise new questions regarding safety and effectivness.