(211 days)
No
The device is described as a manually operated surgical instrument with no mention of computational or data-driven features.
No.
A therapeutic device is one that treats or heals an illness, injury, or disability. This device is a surgical instrument used to cut bone during surgery, which is an interventional tool, not a therapeutic device in itself.
No
The device description clearly states it is a "manually operated instrument indicated for cutting bone during surgery." This describes a surgical tool, not a device used to identify or analyze a medical condition.
No
The device description clearly states it is a "system of disposable manual surgical Kerrison rongeurs," which are physical instruments used for cutting bone. The performance studies also describe mechanical testing of these physical devices.
Based on the provided information, the Steribite® Rongeur is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column." This describes a surgical tool used on the patient's body during a procedure.
- Device Description: The description reinforces this by calling it a "system of disposable manual surgical Kerrison rongeurs."
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The Steribite® Rongeur does not perform this function.
The Steribite® Rongeur is a surgical instrument used directly on the patient's anatomy, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Steribite® Rongeur is a manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column.
Product codes
HAE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skull and 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)
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 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.
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 tests performed:
- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
- Acute systemic toxicity
- Material-mediated pyrogenicity
- Hemolysis
Clinical performance testing was not submitted in this 510(k).
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.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 703 | ||
| Cleveland, OH 44114 | ||
| Sponsor Telephone | (216)241-2804 | |
| 510(k) Contact | Karen E. Warden, PhD | |
| BackRoads Consulting | ||
| PO Box 566 | ||
| Chesterland, OH 44026 | ||
| Office: (440)729-8457 | ||
| Subject Device | ||
| Trade Name | Steribite® | |
| Common Name | Kerrison Rongeur | |
| Regulatory Class | Class II | |
| Classification | 21 CFR 882.4840 | |
| Manual Rongeur | ||
| Product Code | HAE | |
| Predicate Device | ||
| K150428 | Integra® Kerrison Rongeurs | |
| 21 CFR 882.4840 | ||
| Manual Rongeur | ||
| HAE | ||
| Reference Device | ||
| K140927 | Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine | |
| Systems was used to justify the device material (420 stainless steel) in this | ||
| anatomic location (spine). This reference device was used in addition to the | ||
| processing of the materials, manufacturing method, and manufacturing residual | ||
| testing were provided for the subject device. | ||
| Subject Device | ||
| Device Description | 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. | ||
| 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. | ||
| 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 handles | ||
| 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 | |
| operated instrument indicated for cutting | ||
| or biting bone during surgery involving | ||
| the skull or spinal column (Rx). | Integra® Kerrison Rongeurs are | |
| manually operated instruments | ||
| indicated for cutting or biting bone | ||
| during surgery involving the skull or | ||
| spinal column (Rx). | ||
| Manufacturer | RJR Surgical, Inc. | Integra York PA, Inc. |
| Anatomic location | Skull and spine | Skull and spine |
| Patient contacting | ||
| Material | Stainless steel (types 420 and 17-4PH) | Stainless steel (type 420) |
| Basic design | Scissor action grip with translational | |
| slide of the punch shaft to the angled | ||
| footplate | Scissor action grip with translational | |
| slide of the punch shaft to the angled | ||
| 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.
5
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:
-
- Cytotoxicity
-
- Sensitization
- Irritation/intracutaneous reactivity 3.
-
- Acute systemic toxicity
-
- Material-mediated pyrogenicity
-
- 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.