(209 days)
The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
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.
This document describes the premarket notification (510(k)) for the SQ.line KERRISON manual rongeur. It outlines the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed to demonstrate its safety and effectiveness.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cutting Test | Not explicitly stated in detail, but implied to ensure effective cutting after a specified number of uses. | "The test performed confirmed the acceptance criterias were met." (after 25,000 cuttings) |
| Performance Test (Cutting Force) | Implied to define an acceptable range of force required to cut. | "The test performed showed that the applied force meets the acceptance criteria." |
| Mechanical Performance after Reprocessing | Implied to ensure the device maintains functionality and integrity after reprocessing. | "The mechanical performance was assessed after reprocessing and met the acceptance criteria." |
| Biocompatibility | Compliance with ISO 10993 standards for chemical characterization, cytotoxicity, sensitization, irritation, and acute systemic toxicity. | "Test results indicate that the SQ.line KERRISONS are biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices or tests performed per device) for the cutting test, performance test, or mechanical performance after reprocessing.
For biocompatibility, the sample size or specific test article numbers are not provided.
The data provenance is not specified (e.g., country of origin). The studies appear to be internal non-clinical evaluations conducted by the manufacturer, Aesculap, Inc. All studies are retrospectively performed as part of the 510(k) submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, not studies requiring expert interpretation or ground truth establishment in the human diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are non-clinical tests and do not involve human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device is a manual surgical instrument (rongeur), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
For the cutting test, performance test, and mechanical performance after reprocessing, the "ground truth" is established by engineering specifications and predefined performance thresholds based on the device's intended function and safety requirements.
For biocompatibility, the "ground truth" is established by compliance with internationally recognized standards (ISO 10993).
8. The Sample Size for the Training Set
This information is not applicable. The device is a manual surgical instrument and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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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
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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
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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)
< | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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)
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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.
§ 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).