The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

Device Description

The Wiggins Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (AITiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:

Different handles (Large, Standard, for use with Rotating Shafts)
Different shaft lengths (6-14 inches)
Different Bite Sizes (0.5-6 mm)
Different Angles (40° and 90°, up and down)
Different Footplates (Standard, Thin and Ultra-Thin)
With or without ejector
Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

AI/ML Overview

The provided text is an FDA 510(k) summary for Wiggins Medical Surgical Instruments. It details a submission for manual surgical instruments (rongeurs) used for cutting or biting bone during skull or spinal column surgery.

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test)	Reported Device Performance (Result)
Mechanical Strength	The predicate device (Fehling Punches) was subjected to static and dynamic mechanical testing to demonstrate fatigue resistance and cutting displacement in relation to force applied. Result: The subject device (Wiggins Medical Surgical Instruments) is stated to be identical to the predicate in materials, manufacture, design, and function. No further mechanical testing was conducted on the subject device.
Cleaning	A cleaning validation was performed on the worst-case instrument per the process provided in the Instructions for Use (IFU). Result: Instruments were free of visible soil and met acceptance criteria for protein and hemoglobin content per AAMI TIR 30:2011.
Sterilization	A steam sterilization validation was performed using the half-cycle approach. Result: Sterilization parameters will provide a sterility assurance level of 10^-6.
Biocompatibility	The predicate device was deemed biocompatible. Result: The subject device is stated to be identical to the predicate in materials, manufacturing processes, manufacturer, sterilization, and technical specifications. No further biocompatibility testing was required for the subject device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a separate "test set" for the Wiggins Medical Surgical Instruments in the context of typical AI/software device evaluation. Instead, the testing relies heavily on the predicate device (Fehling Punches) for mechanical strength and biocompatibility.

Mechanical Strength: The predicate device was tested. The sample size for this testing is not specified. Data provenance is implied to be from the manufacturer of the predicate device (Gebruder Zepf Medizentechnik GmbH & Co. KG), which is also the manufacturer of the subject device. The nature of these tests (e.g., specific number of cycles for fatigue) is not detailed.
Cleaning: "Worst case instrument" was tested. The specific number of instruments or samples is not specified. The test was performed by the manufacturer of the subject device.
Sterilization: Performed using the "half-cycle approach." The number of samples or cycles is not specified.
Biocompatibility: Relied on the biocompatibility of the predicate device. The underlying data provenance for the predicate's biocompatibility is not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The device is a manual surgical instrument, not an AI/software device that requires expert-established ground truth for its performance evaluation (e.g., diagnostic accuracy). The evaluations are based on physical and biological performance characteristics.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of a "test set" that requires expert adjudication for diagnostic or interpretive outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are typically conducted.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the device is a manual surgical instrument, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for this type of device is established through:

Objective physical testing: Mechanical strength (fatigue resistance, cutting displacement).
Chemical/Biological testing: Cleaning validation (absence of soil, protein, hemoglobin), sterilization (sterility assurance level), and biocompatibility (lack of adverse biological response).
Comparison to a legally marketed predicate device: Substantial equivalence claimed based on identical materials, manufacturing, design, function, and intended use as the predicate device.

8. Sample Size for the Training Set

This is not applicable as the device is a manual surgical instrument and does not involve AI or machine learning models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 21, 2020

Wiggins Medical % Cassandra Petrov Regulatory Engineer JALEX Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K200383

Trade/Device Name: Wiggins Medical Surgical Instruments Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE, HTX Dated: June 15, 2020 Received: June 19, 2020

Dear Cassandra Petrov:

We have reviewed vour 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

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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 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,

Adam D. Pierce, Ph.D. Assistant Director (Acting) 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

510(k) Number (if known) K200383

Device Name Wiggins Medical Surgical Instruments

Indications for Use (Describe)

The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitted By:	Wiggins Medical2230 Park Ave. #202Cincinnati, OH 45206
Date:	July 21, 2020
Contact Person:Contact Telephone:Contact Fax:	Cassandra Petrov, Regulatory Engineer(440) 541-0060(440) 933-7839
Device Trade Name:Device Classification Name:Device Classification:Reviewing Panel:Product Code:Predicate Device:	Wiggins Medical Surgical Instruments882.4840 Manual Rongeur, 888.4540 Orthopedic Manual Surgical InstrumentClass II, Class INeurology, OrthopedicHAE, HTXFehling Punches (K153243)Integra Kerrison Rongeurs (K150428)The predicate device has never been subject to recall.

Device Description:

Different handles (Large, Standard, for use with Rotating Shafts)
Different shaft lengths (6-14 inches) ●
. Different Bite Sizes (0.5-6 mm)
. Different Angles (40° and 90°, up and down)
. Different Footplates (Standard, Thin and Ultra-Thin)
With or without ejector
. Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)

Intended Use:

The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

Summary of Technological Characteristics:

The Wiggins Medical Surgical Instruments are identical to the predicate as they are manufactured by the same company, have the same intended use and the same fundamental scientific technology. Both devices are identical in several aspects which are summarized in the table below. A more detailed

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comparison of the Wiggins Medical Surgical Instruments with predicate and reference predicate devices is included in this submission.

Item	Wiggins MedicalInstruments	Fehling Punches	IntegraKerriosnRongeurs	Equivalence
Intended Use	The Wiggins MedicalSurgical Instrumentsare manuallyoperated, reusablesurgical instrumentsused for cutting orbiting bone duringsurgery involving theskull or spinalcolumn.	Manually operatedinstruments indicatedfor cutting or bitingbone during surgeryinvolving the skull orspinal column	Manuallyoperatedinstrumentsindicatedfor cuttingor bitingboneduringsurgeryinvolvingthe skull orspinalcolumn	Equivalent
Manufacturer	Gebruder ZepfMedizentechnikGmbH & Co. KG	Gebruder ZepfMedizentechnikGmbH & Co. KG	Unknown	Equivalent
Design	Rongeur with a fixedand a sliding shaftand angled footplate	Rongeur with a fixedand a sliding shaftand angled footplate	Rongeurwith afixed and aslidingshaft andangledfootplate	Equivalent
Design Features	Manual, non-electrical, non-sterile,reusable, non-malleable	Manual, non-electrical, non-sterile,reusable, non-malleable	Manual.non-electric,reusable,non-malleable	Equivalent
Materials	420 and 304 StainlessSteel (ASTM F-899),Surface Coating-CERAMO®(TiAIN); Silicone	420 and 304 StainlessSteel (ASTM F-899),Surface Coating-CERAMO®(TiAIN); Silicone	420Stainlesssteel	Equivalent

Table 1. Technological Characteristics Comparison

Verification and Validation Testing:

Test	Test Summary	Result
Mechanical Strength	The Fehling Punches (predicate)were subject to static anddynamic mechanical testing todemonstrate fatigue resistance	The subject device is identical tothe predicate in materials,manufacture, design andfunction. No further mechanicaltesting was conducted.

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	and cutting displacement inrelation to force applied.
Cleaning	A cleaning validation wasperformed on worst caseinstrument per the processprovided in the IFU.	Instruments were free of visiblesoil and met acceptance criteriafor protein and hemoglobincontent per AAMI TIR 30:2011.
Sterilization	A steam sterilization validationwas performed using the halfcycle approach.	Sterilization parameters willprovide a sterility assurancelevel of 10-6.
Biocompatibility	The predicate device wasdeemed biocompatible. Thesubject device is identical to thepredicate in materials,manufacturing processes,manufacturer, sterilization andtechnical specifications.	No further biocompatibilitytesting is required.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

Regulation Number and Section

§ 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).