Steribite® is a system of disposable manual surgical Kerrison rongeurs. The instruments are offered in a 40° up configuration having shaft lengths of 8 and 11 inches and bite sizes 1mm to 5mm to accommodate variations in surgical need. The devices are sold sterile and single use only.

AI/ML Overview

The document describes a 510(k) premarket notification for the "Steribite®" manual rongeur, which is a device used in surgery involving the skull or spinal column. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Mechanical Testing
Cut Performance	Full profile cut in simulated use (based on Steris IMS test standard).	Demonstrated full profile cut in simulated use.
Cut Force	Not explicitly stated as a pass/fail criterion, but assessed against a reference device.	Assessed by applying a controlled load (10-35 pounds) in 5-pound step-wise fashion to cut a 2mm thick bone analog compared to the reference device. (Comparison results are not detailed as specific pass/fail values but implied to be acceptable for substantial equivalence).
Handle Strength	Force to cause failure was at least twice the required cutting force.	Applied a continuous load to failure; demonstrated that the force to cause failure was at least twice the required cutting force.
Sterilization
Sterilization Validation	In accordance with ISO 11137-1:2006 and ISO 11137-2006 for radiation sterilization.	Validation conducted in accordance with specified ISO standards.
Bacterial Endotoxin Testing	In accordance with AAMI ST72:2011/(R)2016.	Testing conducted in accordance with specified AAMI standard.
Packaging
Packaging Performance & Stability	In accordance with ANSI/AAMI/ISO 11607-1:2006/IR)2010.	Testing conducted in accordance with specified ANSI/AAMI/ISO standard.
Biocompatibility
Cytotoxicity	Not explicitly stated, but implies meeting safety standards of ISO 10993-5 Third Edition 2009-06-01.	Assessed for cytotoxicity.
Sensitization	Not explicitly stated, but implies meeting safety standards of ISO 10993-10 Third Edition 1020-08-01.	Assessed for sensitization.
Irritation/Intracutaneous Reactivity	Not explicitly stated, but implies meeting safety standards of ISO 10993-10 Third Edition 1020-08-01.	Assessed for irritation/intracutaneous reactivity.
Acute Systemic Toxicity	Not explicitly stated, but implies meeting safety standards for medical devices.	Assessed for acute systemic toxicity.
Material-Mediated Pyrogenicity	Not explicitly stated, but implies meeting safety standards for medical devices.	Assessed for material-mediated pyrogenicity.
Hemolysis	Not explicitly stated, but implies meeting safety standards for medical devices.	Assessed for hemolysis.
Residual Manufacturing Material Cleanliness	Based on ASTM F2459.	Applied ASTM F2459 to demonstrate residual manufacturing material cleanliness.

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

Sample Size for Test Set: The document mentions "the subject device models, 1-5 mm bite sizes and 8-11 in handles," but does not explicitly state the number of samples (individual devices) used for each mechanical test.
Data Provenance: The data is generated from laboratory testing of the device itself. There is no mention of country of origin for data or whether it's retrospective or prospective, as it pertains to device performance testing rather than clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section is not applicable to this submission. The "Steribite®" is a manual surgical instrument, and its performance and safety validation relies on non-clinical mechanical, sterilization, packaging, and biocompatibility testing against established industry standards and comparison to a predicate device. There is no mention of "ground truth" established by experts in the context of clinical outcomes or diagnostic accuracy, as would be relevant for software or diagnostic devices.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical endpoints, which are not part of this 510(k) submission for a manual surgical instrument.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI/radiology devices where human readers' performance is augmented by AI. The Steribite® is a manual surgical rongeur, not an AI or diagnostic device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone study was not performed. This device is a manual surgical instrument and does not incorporate an algorithm or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This section is not applicable in the traditional sense. The "ground truth" for the non-clinical tests conducted is defined by established engineering principles, industry standards (e.g., ISO, AAMI, ASTM), and the expected performance characteristics of a manual rongeur compared to its predicate. For example, for "cut performance," the ground truth is a "full profile cut in simulated use" as per a specific test standard.

8. The sample size for the training set

Not Applicable. This device is a mechanical surgical instrument and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, there is no ground truth established for one.

Summary

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November 8, 2018

RJR Surgical, Inc. % Karen Warden Representative/Consultant BackRoads Consulting, Inc. PO Box 566 Chesterland, Ohio 44026-0566

Re: K180949

Trade/Device Name: Steribite® Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: October 4, 2018 Received: October 9, 2018

Dear Karen Warden:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Matthew C. Krueger -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180949

Device Name Steribite®

Indications for Use (Describe)

The Steribite® Rongeur is a manually operated instrument indicated for cutting 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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K180949 510(k) Summary

Date	November 6, 2018
Sponsor	RJR Surgical, Inc.2530 Superior Avenue, STE 703Cleveland, OH 44114
Sponsor Telephone	(216)241-2804
510(k) Contact	Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: (440)729-8457
Subject Device
Trade Name	Steribite®
Common Name	Kerrison Rongeur
Regulatory Class	Class II
Classification	21 CFR 882.4840Manual Rongeur
Product Code	HAE
Predicate Device
K150428	Integra® Kerrison Rongeurs21 CFR 882.4840Manual RongeurHAE
Reference Device
K140927	Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS SpineSystems was used to justify the device material (420 stainless steel) in thisanatomic location (spine). This reference device was used in addition to theprocessing of the materials, manufacturing method, and manufacturing residualtesting were provided for the subject device.
Subject Device
Device Description	Steribite® is a system of disposable manual surgical Kerrison rongeurs. Theinstruments are offered in a 40° up configuration having shaft lengths of 8 and 11inches and bite sizes 1mm to 5mm to accommodate variations in surgical need.The devices are sold sterile and single use only.
Intended Use	The Steribite® Kerrison rongeur is a manually operated instrument indicated forcutting or biting bone during surgery involving the skull or spinal column.
Materials of Use	The shaft portion of the device is manufactured from stainless steels (420 and 17-4PH for patient contacting; 302 and 316 for rivet pins and springs). The handlesare manufactured from polyarylamide resin (type IXEF PARA GS-1022, Solvay).

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Table: Technological Characteristics as Compared to the Predicate Device

Steribite® possesses similar technological characteristics as compared to the predicate device K150428. Different characteristics do not raise different questions of safety and effectiveness, and scientific methods were applied to evaluate different characteristics' effects on safety and effectiveness.

	Subject Device	Predicate Device
	K180949	K150428
Trade Name	Steribite®	Integra® Kerrison Rongeurs
Indications for Use	The Steribite® Rongeur is a manuallyoperated instrument indicated for cuttingor biting bone during surgery involvingthe skull or spinal column (Rx).	Integra® Kerrison Rongeurs aremanually operated instrumentsindicated for cutting or biting boneduring surgery involving the skull orspinal column (Rx).
Manufacturer	RJR Surgical, Inc.	Integra York PA, Inc.
Anatomic location	Skull and spine	Skull and spine
Patient contactingMaterial	Stainless steel (types 420 and 17-4PH)	Stainless steel (type 420)
Basic design	Scissor action grip with translationalslide of the punch shaft to the angledfootplate	Scissor action grip with translationalslide of the punch shaft to the angledfootplate
Dimensions
Shaft length	8 and 11 inches	4.75 to 15 inches
Footplate	40°, up	40° and 90°, up/down
Bite width	1 to 5mm, 1mm increments	1 to 6mm, 1mm increments
Sterilization	Provided sterile, single use	End user sterilized, reusable

Non-Clinical Performance Testing Submitted to Demonstrate Substantial Equivalence

Mechanical testing was performed to assess the performance of the subject device models, 1-5 mm bite sizes and 8-11 in handles, as compared to a similar reference device, K150468, K2 Manual Rongeur:

Cut performance: Steris IMS test standard was applied to demonstrate full profile cut in simulated use.
Cut force: a controlled load ranging from 10-35 pounds was applied to the handles of each device under ● test in a stepwise fashion (5 pounds) to assess cut force for a 2mm thick bone analog compared to the reference device.
. Handle strength: A continuous load to failure was applied to the devices to demonstrate that the force to cause failure was least twice the required cutting force.

Sterilization

Sterilization validation was conducted in accordance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirement, validation, and routine control of a sterilization process for medical devices and ISO 11137-2006, Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose.

Bacterial endotoxin testing was conducted in accordance with AAMI ST72:2011/(R)2016, Bacterial Endotoxins Test methods, routine monitoring, and alternatives to batch testing.

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The packaging performance and stability testing were conducted in accordance with ANSI/AAMI/ISO 11607-1:2006/IR)2010 Packaging for terminally sterilized medical devices-Part 1: Requirements for materials. sterile barrier systems, and packaging systems.

Biocompatibility

The Steribite Rongeur is categorized as an external communicating device with limited contact (≤24 h) with tissue/bone, cerebrospinal fluid (CSF), and blood (indirect contact with blood through CSF as CSF is reabsorbed into the venous system). The appropriate biocompatibility endpoints that were assessed include:

1. Cytotoxicity
1. Sensitization
Irritation/intracutaneous reactivity 3.
1. Acute systemic toxicity
1. Material-mediated pyrogenicity
1. Hemolysis

ISO 10993-5 Third Edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10 Third Edition 1020-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ASTM F2459 was applied to demonstrate residual manufacturing material cleanliness

Clinical performance testing was not submitted in this 510(k).

Conclusion

Steribite® possesses indications for use and technological characteristics similar to the predicate devices. The performance testing demonstrated that the device is as safe and effective as the predicate and performs as well as the predicate. Therefore, Steribite® is substantially equivalent to the predicate.

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).