(270 days)
Vitalitec Kerrison Rongeurs are manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
The Vitalitec Medizintechnik GmbH Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: 1-6 mm bite sizes; 14 mm - 16 mm jaw openings; 40° and 90° up/down cutting angles; regular and thin footplates; various handle and shaft styles; sliding shaft; detachable.
A rongeur is a robust constructed reusable surgical instrument with sharp, spoon shaped working ends, which used for cutting or biting bone during surgery involving the skull or spinal column.In Neurosurgery a rongeur is used for grasping and dissecting of bone and tissue during neurosurgical and orthopedic procedures.
This document is a 510(k) summary for the Vitalitec Kerrison Rongeurs, a manual surgical instrument. It compares the device to a predicate device (Integra Kerrison Rongeurs, K092227) to demonstrate substantial equivalence, rather than describing a study to prove acceptance criteria for an AI-powered device. Therefore, most of the requested information regarding AI device evaluation is not applicable here.
However, I can extract the information relevant to this specific device (a manual surgical instrument) as best as possible.
Device Overview:
- Device Name: Vitalitec Kerrison Rongeurs
- Regulation Number: 21 CFR 882.4840
- Regulation Name: Manual Rongeur
- Regulatory Class: Class II
- Product Code: HAE
- Indications for Use: Manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
- Predicate Device: Integra LifeSciences Corporation device, Integra™ Kerrison Rongeurs, cleared under 510(k) K092227.
1. Table of Acceptance Criteria and Reported Device Performance
For this manual surgical instrument, "acceptance criteria" are implied by the performance standards it needs to meet to be considered substantially equivalent to the predicate device and to ensure safe and effective use. These are primarily mechanical performance and compliance with relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of results) |
|---|---|
| Mechanical Performance (Cutting/Bite Force): Equivalent or better than predicate device. | Mechanical testing was performed. 100% inspection of samples of both the predicate and proposed Kerrison Rongeurs met the requirements of DIN 58298. Test showed the measured functional specifications of the Vitalitec Kerrison rongeurs were equivalent or better than comparable specifications of the predicate device. |
| Sterility: Information for reprocessing (sterilization) provided. | Tested in accordance with AAMI / ANSI ST81:2004/(R)2010 (Sterility) and ISO 17665-1 First edition 2006-08-15 (Sterilization of health care products - moist heat). Reprocessing cleaning and disinfection validation studies performed in accordance with FDA Draft Guidance: Processing/Reprocessing Medical Devices in Health Care Settings. |
| Biocompatibility: Meets relevant standards for patient contact materials. | Tested in accordance with AAMI / ANSI / ISO 10993-1:2009/(R) 2013 (Biocompatibility). |
| Material Composition: Complies with surgical instrument material standards. | Tested in accordance with ISO 7153-1 Second edition 1991-04-01 (Surgical instruments - metallic materials -- part 1: stainless steel). Materials are 1.4021 (420 SS) composition X20Cr13 according to DIN EN ISO 7153-1. |
| Risk Management: Application of risk management to medical devices. | Tested in accordance with ISO 14971 Second edition 2007-03-01 (Medical devices - application of risk management). |
| Labeling/Symbols: Use of standard symbols for medical device labels and information. | Tested in accordance with ISO 15223-1 Second Edition 2012-07-01 (Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied). |
| Functional Equivalence: Performs cutting/biting bone as intended without new safety issues. | "The design, operational principle and technology of cutting bone are identical to Integra predicate Rongeurs. The material is captured and removed the same as the predicate device. The mechanical cut... is identical to the predicate." |
2. Sample size used for the test set and the data provenance
- Sample Size: For the mechanical testing, it states "100% Inspection resulted in all samples of both the predicate and the proposed Kerrison Rongeur meeting the requirements of DIN 58298." This implies that all units (or a representative batch) used for the mechanical comparison were inspected. The exact number of units is not specified, but the "100% inspection" suggests a complete evaluation of the test batch.
- Data Provenance: Not specified in terms of country of origin. The study appears to be a laboratory-based, non-clinical performance test conducted by the manufacturer to compare their device against a predicate, following international standards. It is a prospective test in the sense that the new device was subjected to defined tests under controlled conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI device or a diagnostic device requiring expert interpretation of results. The "ground truth" for this manual surgical instrument is established by objective mechanical performance tests (e.g., cutting a specific material) and compliance with recognized standards for materials, biocompatibility, and sterilization, rather than expert annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per the answer to question 3, there's no diagnostic output or subjective assessment that would require an adjudication method. The testing results are objective measurements against defined standards.
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
- Not Applicable. This is not an AI device, therefore no MRMC study involving human readers and AI assistance was conducted or is relevant. This is a manual surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by objective technical and mechanical testing standards and compliance with recognized international standards (e.g., DIN 58298 for cutting, ISO 10993 for biocompatibility, AAMI ST81 for sterilization). Equivalence to the predicate device's performance also serves as a benchmark.
8. The sample size for the training set
- Not Applicable. This is not an AI device; therefore, there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI device, there is no training set and no ground truth established for it.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a connection to health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2016
Vitalitec Medizintechnik GmbH % Ms. Lynette Howard President Lyle Howard Corporation 106 East 5th Avenue Mount Dora, Florida 32757
Re: K152734
Trade/Device Name: Vitalitec Kerrison Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: May 17, 2016 Received: May 20, 2016
Dear Ms. Howard:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -$=D/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K152734
Device Name Vitalitec Kerrison Rongeurs
Indications for Use (Describe)
Vitalitec Kerrison Rongeurs 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
Device Submitter
Vitalitec Medizintechnik GmbH Steigäcker 20 Balgheim (Baden-Wurttemberg) 78582 Germany
Phone: 908.788.4580 Fax: 352.383.8338
Contact Person: Lynette Howard Date Prepared: June 16, 2016
Establishment Registration Number: 8044057
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: Vitalitec Kerrison Rongeurs Common Name: Kerrison Rongeurs Classification Name: Class II, 21 CFR 882.4840, Product Code: HAE
Predicate Device [21 CFR 807.92(a)(3)]
For this submission, Vitalitec Medizintechnik GmbH has chosen the Integra LifeSciences Corporation device, IntegraTM Kerrison Rongeurs, cleared under 510(k) K092227.
The Integra LifeSciences Corporation rongeur is a class II device according to 21 CFR 882.4840. Product Code HAE.
Description of the Device [21 CFR 807.92(a)(4)]
The Vitalitec Medizintechnik GmbH Kerrison Rongeur is a class II device according to 21 CFR 882.4840, Product Code HAE.
The Vitalitec Medizintechnik GmbH Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: 1-6 mm bite sizes; 14 mm - 16 mm jaw openings; 40° and 90° up/down cutting angles; regular and thin footplates; various handle and shaft styles; sliding shaft; detachable.
A rongeur is a robust constructed reusable surgical instrument with sharp, spoon shaped working ends, which used for cutting or biting bone during surgery involving the skull or spinal
{4}------------------------------------------------
column.In Neurosurgery a rongeur is used for grasping and dissecting of bone and tissue during neurosurgical and orthopedic procedures.
Indications for Use
Vitalitec Kerrison Rongeurs are manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
Technological Characteristics [21 CFR 807.92(a)(6)]
The subject device is similar in design, indications for use, and mechanical performance to the predicate device.
| Characteristic | Subject | Predicate |
|---|---|---|
| 510(k) # | K152734 | K092227 |
| Class | II | II |
| Product Code | HAE | HAE |
| Regulation # | 882.4840 | 882.4840 |
| ClassificationName | Manual, Rongeur | Manual, Rongeur |
| Trade Name | Vitalitec Kerrison Rongeurs | Integra™ (Jarit®, Ruggles™, R&BRedmond™, (Redmond™),Miltex®, MeisterHand®) Kerrisonrongeurs |
| Indications for Use | Vitalitec Kerrison Rongeurs aremanually operated reusablesurgical instruments used forcutting or biting bone duringsurgery involving the skull orspinal column. | Integra™ (Jarit®, Ruggles™, R&BRedmond™, (Redmond™),Miltex®, MeisterHand®) Kerrisonrongeurs are manually operatedinstruments indicated for cutting orbiting bone during surgery involvingthe skull or spinal column. |
| Materials - PatientContact -Transient Use | Handle, Shaft, Jaw Parts:Stainless steel 1.4021 (420 SS)composition X20Cr13 accordingto DIN EN ISO 7153-1Surface Coating:Titanium-aluminium-nitridecoating (TiAIN) | 420 Stainless steelSurface Coatings:Titanium-Diamond coat & Hardcoat™-nitride coating (TiAIN);Titanium Nitride (TiN); Stealth coat& Smooth-coat™ (Dicronite DL-5);Ultra-coat™ (ZrN); PTFE(polytetrafluoroethylene (Teflon®);Silicon (Elastosil® LR3003/80 A,B) |
| Packaging | Shipped non-sterile | Shipped non-sterile |
| Type of Device | Reusable Surgical Instrument | Reusable Surgical Instrument |
{5}------------------------------------------------
| Characteristic | Subject | Predicate |
|---|---|---|
| 510(k) # | K152734 | K092227 |
| Class | II | II |
| Product Code | HAE | HAE |
| Regulation # | 882.4840 | 882.4840 |
| Classification | Manual, Rongeur | Manual, Rongeur |
| Name | ||
| Sterility | Sterilizable | Sterilizable |
| Utility | Reusable | Reusable |
| TechnologicalPrinciples | Rongeurs (Kerrisons) are manualsurgical instruments constructedwith a scoop-shaped cutting tipwhich also compresses and cutsbone. | The only difference is that the upperslide of the Integra moves upward,where the Vitalitec upper shaftmoves sideways to detach forcleaning. |
| Elements | Instrument body, movablehandle to activate jaws, scoopshaped cutting tip. | Instrument body, movable handle toactivate jaws, scoop shaped cuttingtip. |
The Vitalitec Medizintechnik GmbH Kerrison Rongeur is substantially equivalent to the predicate device since the basic features and the intended uses are the same. The only difference in design between the predicate is that the upper slide of the Integra moves upward, where the Vitalitec upper shaft moves sideways to detach for cleaning. The predicate device is available with additional coatings that are not used by Vitalitec. The minor differences between the Vitalitec Medizintechnik GmbH Kerrison Rongeur and the predicate device raise no new issues of safety and effectiveness. These differences have no effect on the function or intended use of the device.
Performance Data [21 CFR 807.92(b)(1)]
The Vitalitec Medizintechnik GmbH Kerrison Rongeurs have been successfully tested for its functions, performance, and safety as per FDA recognized standards including:
Recognition Number 14-295: AAMI / ANSI ST81:2004/(R)2010, sterilization of medical devices - information to be provided by the manufacturer for the processing of resterilizable medical devices. (Sterility)
Recognition Number 5-40: ISO 14971 Second edition 2007-03-01, medical devices application of risk management to medical devices. (General I (QS/RM))
Recognition Number 5-90: ISO 15223-1 Second Edition 2012-07-01, medical devices symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements. (General I (QS/RM))
{6}------------------------------------------------
Recognition Number 2-156: AAMI / ANSI / ISO 10993-1:2009/(R) 2013, biological evaluation of medical devices -- part 1: evaluation and testing within a risk management process. (Biocompatibility)
Recognition Number 8-344: ISO 7153-1 Second edition 1991-04-01. surgical instruments -metallic materials -- part 1: stainless steel [including: amendment 1 (1999)]. (Materials)
Recognition Number 14-333: ISO 17665-1 First edition 2006-08-15, sterilization of health care products - moist heat - part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
| Test | Test Method Summary | Results |
|---|---|---|
| MechanicalTestingCuttingperformancetesting/biteforce | Mechanical testing was performed tocompare functional requirements ofthe Vitalitec Kerrison Rongeurs withthe predicate device. Cutting ofcontrol carton 250g/m2 according toDIN 58298 using both the predicateand proposed Kerrison Rongeur. | 100% Inspection resulted in all samples ofboth the predicate and the proposed KerrisonRonguers meeting the requirements of DIN58298, resulting in the determination ofsubstantial equivalence. Test showed themeasured functional specifications of theVitalitec Kerrison rongeurs were equivalentor better than comparable specifications ofthe predicate device. |
Reprocessing:
Vitalitec Medizintechnik GmbH Kerrison Rongeurs cleaning and disinfection validations studies were performed in accordance with FDA Draft Guidance : Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (May 2, 2011) The subject device is shipped non-sterile and is intended to be sterilized by user.
Clinical Data [21 CFR 807.92(b)(2)]
Clinical data was not used to determine substantial equivalence.
Conclusion [21 CFR 807.92(b)(3)]
Substantial equivalence for this device is based on similarities in intended use, function (design and technology), performance, and operational principle to the predicate device. Integra Kerrison Rongeurs (K092227).
The Vitalitec Medizintechnik GmbH Kerrison Rongeurs intended use and indications for use is identical to the Integra Kerrison Rongeurs (K092227) for cranial and spine applications: Neurosurgery.
{7}------------------------------------------------
The material used for the Vitalitec Medizintechnik GmbH Kerrison Rongeur is the same material as used for the Integra predicate Rongeur. The only difference is that the Integra devices have additional coating materials that are not used by Vitalitec.
The design, operational principle and technology of cutting bone are identical to Integra predicate Rongeurs. The material is captured and removed the same as the predicate device. The mechanical cut of the Vitalitec Medizintechnik GmbH Kerrison Rongeur is identical to the predicate. The only technological difference is that the upper slide of the Integra moves upward, where the Vitalitec upper shaft moves sideways to detach for cleaning. This does not impact the intended use of the device.
Based on predicate analysis as well as non-clinical performance testing, Vitalitec Medizintechnik GmbH has demonstrated the subject device is identical to the predicate in performance based on intended use. The results of the testing confirmed that Vitalitec Medizintechnik GmbH Kerrison Rongeurs and Integra Kerrison Rongeurs performed as intended.
Due to the similarity of the intended use, indications of use, function, materials, performance, and operational principle to the predicate device, Vitalitec Medizintechnik GmbH believes that the Vitalitec Medizintechnik GmbH Kerrison Rongeur does not raise any new safety or effectiveness issues.
§ 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).