Steribite

K180949 · Rjr Surgical, Inc. · HAE · Nov 8, 2018 · Neurology

Device Facts

• Record ID: K180949
• Device Name: Steribite
• Applicant: Rjr Surgical, Inc.
• Product Code: HAE · Neurology
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Steribite® Kerrison rongeur is a manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column.

Device Story

Steribite® is a system of disposable, single-use, manual Kerrison rongeurs used by surgeons in skull or spinal column procedures. The device features a scissor-action grip with a translational slide mechanism that moves a punch shaft toward an angled footplate to cut bone. It is provided sterile. The surgeon operates the device manually to remove bone tissue, facilitating surgical access or decompression. The device is intended to provide a sterile, single-use alternative to reusable rongeurs, reducing the risk of cross-contamination and eliminating the need for reprocessing.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by non-clinical bench testing, including cut performance (Steris IMS standard), cut force analysis (10-35 lbs load), and handle strength testing (load to failure). Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis) and sterilization validation (ISO 11137) were performed.

Technological Characteristics

Manual Kerrison rongeur; scissor-action grip with translational slide. Materials: 420 and 17-4PH stainless steel (patient-contacting), 302/316 stainless steel (pins/springs), polyarylamide resin (IXEF PARA GS-1022 handles). Dimensions: 8 and 11-inch shaft lengths, 40° up footplate, 1-5mm bite widths. Sterilization: Radiation (ISO 11137). Packaging: ANSI/AAMI/ISO 11607. Biocompatibility: ISO 10993-5, ISO 10993-10, ASTM F2459.

Indications for Use

Indicated for cutting or biting bone during surgery involving the skull or spinal column in patients requiring such procedures.

Regulatory Classification

Identification

A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

Predicate Devices

• Integra® Kerrison Rongeurs (K150428)

Reference Devices

• Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems (K140927)
• K2 Manual Rongeur (K150468)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>2530 Superior Avenue, STE 703<br>Cleveland, OH 44114 | |
| Sponsor Telephone | [phone] | |
| 510(k) Contact | Karen E. Warden, PhD<br>BackRoads Consulting<br>PO Box 566<br>Chesterland, OH 44026<br>Office: [phone] | |
| Subject Device | | |
| Trade Name | Steribite® | |
| Common Name | Kerrison Rongeur | |
| Regulatory Class | Class II | |
| Classification | 21 CFR 882.4840<br>Manual Rongeur | |
| Product Code | HAE | |
| Predicate Device | | |
| K150428 | Integra® Kerrison Rongeurs<br>21 CFR 882.4840<br>Manual Rongeur<br>HAE | |
| Reference Device | | |
| K140927 | Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine<br>Systems was used to justify the device material (420 stainless steel) in this<br>anatomic location (spine). This reference device was used in addition to the<br>processing of the materials, manufacturing method, and manufacturing residual<br>testing were provided for the subject device. | |
| Subject Device | | |
| Device Description | Steribite® is a system of disposable manual surgical Kerrison rongeurs. The<br>instruments are offered in a 40° up configuration having shaft lengths of 8 and 11<br>inches and bite sizes 1mm to 5mm to accommodate variations in surgical need.<br>The devices are sold sterile and single use only. | |
| Intended Use | The Steribite® Kerrison rongeur is a manually operated instrument indicated for<br>cutting 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-<br>4PH for patient contacting; 302 and 316 for rivet pins and springs). The handles<br>are 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 manually<br>operated instrument indicated for cutting<br>or biting bone during surgery involving<br>the skull or spinal column (Rx). | Integra® Kerrison Rongeurs are<br>manually operated instruments<br>indicated for cutting or biting bone<br>during surgery involving the skull or<br>spinal column (Rx). |
| Manufacturer | RJR Surgical, Inc. | Integra York PA, Inc. |
| Anatomic location | Skull and spine | Skull and spine |
| Patient contacting<br>Material | Stainless steel (types 420 and 17-4PH) | Stainless steel (type 420) |
| Basic design | Scissor action grip with translational<br>slide of the punch shaft to the angled<br>footplate | Scissor action grip with translational<br>slide of the punch shaft to the angled<br>footplate |
| 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
- 2. Sensitization
- Irritation/intracutaneous reactivity 3.
- 4. Acute systemic toxicity
- 5. Material-mediated pyrogenicity
- 6. 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.