(269 days)
Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Fehling-Punches are reusable stainless steel instruments that are coated with CERAMO® that are sterilizable and packaged non-sterile. The instruments are offered in various sizes and with different features to accommodate the variations of patient anatomy and access. Instruments are available with the following features: 0.8-8 mm bite sizes; 9 – 19 mm jaw openings; 40° and 90° up/down cutting angles; up/down curved; reqular and thin profile footplates; standard and ejector tips; 110 - 400 mm shaft lengths; and various handle and shaft styles, detachable and non-detachable. Fehling-Punches are distributed under the following brand names: CERAMO® CONCEPT X, CERAMO® CONCEPT CLASSIC, CERAMO® CONCEPT APART, CERAMO® GENTLE, CERAMO® GENTLE "SINGER", CERAMO® TRADITION X, CERAMO® FIST. CERAMO® EJECTOR, CERAMO® SUBLAMINAR, CERAMO® APART, CERAMO® KERRISION. The instruments are made of stainless steel according to ASTM F899 and are coated with CERAMO®. CERAMO®is an AlTiN coating. A reusable screwdriver (item code TXW-9X) is offered with the Fehling Punches for the assembly and disassembly.
The acceptance criteria table and device performance based on the provided document are as follows. Please note that the document does not describe a study involving an AI/algorithmic device. The device described is a manual surgical instrument (bone punches). Therefore, many of the requested categories related to AI/MRMC studies, ground truth methodology, and training/test set details are not applicable as they pertain to AI algorithms, not manual instruments.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | No cytotoxic potential | No cytotoxic potential to L-929 mouse fibroblast cells. |
| Sensitization | Not considered a sensitizer (per ISO 10993-10) | Not considered a sensitizer in the guinea pig maximization model. |
| Hemolysis | Non-hemolytic | Direct contact and extract were non-hemolytic (mean hemolytic index < 2%). |
| Acute Systemic Toxicity | No significant systemic toxicity or mortality (per ISO 10993-11) | No evidence of significant systemic toxicity or mortality. |
| Intracutaneous Study | Met requirements of Intracutaneous injection test (per ISO 10993-10) | Met requirements of the Intracutaneous injection test. |
| Pyrogenicity | Non-pyrogenic (for devices that have undergone validated cleaning and sterilization) | Non-pyrogenic. |
| LAL-Test (Bacterial Endotoxin) | Non-pyrogenic (for devices that have undergone validated cleaning and sterilization) | Non-pyrogenic. |
| Performance Testing | ||
| Dynamic (Fatigue Resistance) | Maintained integrity after 12,500 cutting simulations | Confirmed integrity after 12,500 cutting simulations. |
| Static (Cutting Force) | Comparable mean force required to operate to predicate device | Mean force required comparable to the predicate device. |
| Coating Thickness Verification | Coating thickness present on all relevant surface areas and within an advantageous range | Coating thickness verified to be present and within an advantageous range. |
| Dimensional Verification | Conformed to actual specifications | Dimensional and functional specifications verified. |
| Performance Tests | Passed defined parameters for worst-case and extended use | Devices passed tests (one deviation noted but attributed to misplacement). |
| Processing Validation | ||
| Automated Cleaning Validation | Automated cleaning validated (per AAMI TIR 30) | Automated cleaning was validated. |
| Sterilization Validation | Sterilization process validated (per ISO 17665, AAMI TIR 30) | Sterilization process was validated (full cycle 132°C and 4 min). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical laboratory testing of physical device properties and biocompatibility, not analysis of a "test set" of data in the context of an AI/algorithmic device. Therefore, typical metrics for data-driven test sets (e.g., country of origin, retrospective/prospective) are not applicable.
- Biocompatibility Tests: Sample sizes for each specific biocompatibility test (cytotoxicity, sensitization, etc.) are not explicitly stated within the summary, but they were conducted on the "Fehling-Punches" device.
- Performance Tests: The "dynamic test" involved 12,500 cutting simulations, implying a test set for fatigue evaluation. Other performance tests (static, coating, dimensional) were conducted on the device itself.
- Data Provenance: The tests were conducted by the manufacturer or their contracted labs as part of the 510(k) submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a manual surgical instrument, and its performance was evaluated through laboratory testing and engineering analysis against established standards and predicate devices, not by human experts establishing "ground truth" in the context of an AI algorithm's output.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" requiring adjudication by multiple experts in the context of an AI device. Performance was determined by objective measurements and standardized testing protocols.
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
This is not applicable. The device is a manual surgical instrument and does not involve AI assistance or human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical, manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Established industry standards: E.g., ISO 10993 for biocompatibility, AAMI TIR 30 and ISO 17665 for cleaning and sterilization.
- Comparison to legally marketed predicate devices: Establishing substantial equivalence by demonstrating similar performance characteristics (e.g., cutting force, fatigue resistance) and safety profiles.
- Dimensional and functional specifications: Internal engineering and design specifications for the device.
8. The Sample Size for the Training Set
This is not applicable. The device is a manually operated surgical instrument, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There was no training set or AI algorithm involved.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2016
Fehling Instruments GmbH & Co. KG % Mr. Arne Briest CEO VISAMED GmbH Kastellstr. 8 Karlsruhe D-76227 Germany
Re: K153243
Trade/Device Name: Fehling Punches Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: July 4, 2016 Received: July 6. 2016
Dear Mr. Briest:
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
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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,
| William J. | Digitally signed by William J. Heetderks -A |
|---|---|
| Heetderks -A | DN: c=US, o=U.S. Government, ou=HHS, |
| ou=NIH, ou=People, | |
| 0.9.2342.19200300.100.1.1=0010149848, | |
| cn=William J. Heetderks -A | |
| Date: 2016.08.04 15:18:14 -04'00' |
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) K153243
Device Name Fehling Punches
Indications for Use (Describe)
Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/2 description: The image contains the text "FEHLING INSTRUMENTS" in a light blue color. The word "FEHLING" is on the top line, and the word "INSTRUMENTS" is on the bottom line. The text is simple and clean, and the overall impression is one of professionalism and precision.
510(k) Summary
1. Submission Sponsor and Application Correspondent
A. Submission Sponsor
Fehling Instruments GmbH & Co. KG Hanauer Landstr. 7A D-63791 Karlstein Germany
Phone: + 49 6188 9574 - 0 Fax: + 49 6188 9574 - 46 Contact: Mrs. Ulrike Lindner
FDA Establishment Registration #:
9615005
B. Application Correspondent
VISAMED GmbH Kastellstr. 8 D-76227 Karlsruhe Germany
| Phone: | +49-721-476-4847 |
|---|---|
| Fax: | +49-721-476-4849 |
| Contact: | Mr. Arne Briest |
Date Prepared 2.
Date Prepared:
August 2, 2016
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3. Device Identification
Trade/Proprietary Name:
Fehling Punches CERAMO® CONCEPT X CERAMO® CONCEPT CLASSIC CERAMO® CONCEPT APART CERAMO® GENTLE CERAMO® GENTLE "SINGER" CERAMO® TRADITION X CERAMO® FIST CERAMO® EJECTOR CERAMO® SUBLAMINAR CERAMO® APART CERAMO® KERRISION
Common/Usual Name: Classification Name: Classification Regulation Product Code: Device Class: Classification Panel
Rongeur, Manual Manual Rongeur 21 CFR 882.4840 HAE Class II Neurology
4. Legally Marketed Predicate Device
K150428 - Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs, cleared April 16, 2015
K092227 - Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs, cleared February 17, 2010
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5. Device Description
Fehling-Punches are reusable stainless steel instruments that are coated with CERAMO® that are sterilizable and packaged non-sterile.
The instruments are offered in various sizes and with different features to accommodate the variations of patient anatomy and access. Instruments are available with the following features: 0.8-8 mm bite sizes; 9 – 19 mm jaw openings; 40° and 90° up/down cutting angles; up/down curved; reqular and thin profile footplates; standard and ejector tips; 110 - 400 mm shaft lengths; and various handle and shaft styles, detachable and non-detachable. Fehling-Punches are distributed under the following brand names: CERAMO® CONCEPT X, CERAMO® CONCEPT CLASSIC, CERAMO® CONCEPT APART, CERAMO® GENTLE, CERAMO® GENTLE "SINGER", CERAMO® TRADITION X, CERAMO® FIST. CERAMO® EJECTOR, CERAMO® SUBLAMINAR, CERAMO® APART, CERAMO® KERRISION
The instruments are made of stainless steel according to ASTM F899 and are coated with CERAMO®. CERAMO®is an AlTiN coating.
A reusable screwdriver (item code TXW-9X) is offered with the Fehling Punches for the assembly and disassembly.
6. Indications for Use
Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
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7. Substantial Equivalence Discussion
| new device | PredicateIntegra (KerrisonRongeurs) | PredicateIntegra (KerrisonRongeurs) | |
|---|---|---|---|
| 510(k) | K153243 | K150428 | K092227 |
| Product Code | HAE | HAE | HAE |
| Class | II | II | II |
| Regulation # | 882.4840 | 882.4840 | 882.4840 |
| Classification Name | Manual, Rongeur | Manual, Rongeur | Manual, Rongeur |
| Indication for use | FEHLING rongeurs(bone punches) aremanually operatedinstrumentsindicated for cuttingor biting bone duringsurgery involving theskull or spinalcolumn. | Integra KerrisonRongeurs are manuallyoperated instrumentsindicated for cutting orbiting bone duringsurgery involving theskull or spinal column. | Integra KerrisonRongeurs are manuallyoperated instrumentsindicated for cutting orbiting bone duringsurgery involving theskull or spinal column. |
| Sterility | Non Sterile | Non Sterile | Non Sterile |
| Cleaning | Instrument can beprocessed in avalidated washer-disinfector priorsterilization | Instrument can beprocessed in avalidated washer-disinfector priorsterilization | Instrument can beprocessed in avalidated washer-disinfector priorsterilization |
| Material | 420 and 304StainlessSteels (ASTM F-899);Surface coatings:CERAMO® (TiAIN);Silicone | 420 Stainless steelSurface coatings:Titanium Nitride(TiN);Diamond Coat andHard-Coat™ (TiAIN);Stealth Coat andSmooth-Coat™(Dicronite DL-5);Ultra-Coat™ (ZrN);PTFE(polytetrafluoroethylene[Teflon®]);Silicone (Elastosil®LR3003/80 A,B) | medical gradestainless steel (ASTMF-899) |
| Design Features | Manual,non-electrical,non-sterile,reusable,non-malleable | Manual,non-electrical,non-sterile,reusable,non-malleable | Manual,non-electrical,non-sterile,reusable,non-malleable |
| new device | PredicateIntegra (KerrisonRongeurs) | PredicateIntegra (KerrisonRongeurs) | |
| Design | Rongeur with afixed and a slidingshaft and angledfootplate Rongeurwith one fixed shaft,one sliding shaftand a mouthpart | Rongeur with a fixedand a sliding shaft andangled footplateRongeur with one fixedshaft, one sliding shaftand a mouthpart | Rongeur with a fixedand a sliding shaft andangled footplateRongeur with one fixedshaft, one sliding shaftand a mouthpart |
| Tip | Scoop-shaped tip,various angles andsizes (see below) | Scoop-shaped tip,various angles andsizes (see below) | Scoop-shaped tip,various angles andsizes |
| Shaft length | 110 - 400 mm | 4.75 - 15"(approximately121 mm - 381 mm) | 4.75 - 15"(approximately121 mm - 381 mm) |
| Jaw opening | 9 – 19 mm | 9 – 15,5 mm | 9 – 15,5 mm |
| Bit Size | 0.8 – 8 mm | 1 – 6 mm | 1 – 6 mm |
| Cuttingangulation | 40° and 90°up/down | 40° and 90° up/down | 40° and 90° up/down |
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The Fehling Punches have the same intended use, similar performance characteristics, are manufactured from similar materials and are similar in design to the predicate devices.
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8. Non-Clinical Performance Data
Biocompatibility
Biocompatibility testing on the Fehling-Punches was conducted and evaluated per ISO 10993.
Cytotoxicity
The full strength EMEM10 test article showed no cytotoxic potential to L-929 mouse fibroblast cells.
Sensitization
The topical application of the 0.9% NaCl extract did not induce delayed sensitization in the quinea pig. The topical application of the sesame oil extract did not induce delayed sensitization in the guinea pig. Based on these test results, according to the ISO 10993-10 standard, the test article was not considered a sensitizer in the quinea pig maximization model.
Hemolysis
The mean hemolytic index for the test article by direct contact was of 1.40%, and the mean hemolytic index for the test article extracted was of 1.95%. The direct contact of the test article was non hemolytic and the test article extract was non hemolytic. The negative and positive controls performed as anticipated.
Acute Systemic Toxicity Study in Mice
There was no evidence of significant systemic toxicity or mortality after test article extracts injection. Each test article extracted met the requirements of the ISO 10993-11 standard.
Intracutaneous Study in Rabbits
The 0.9 % NaCL and sesame oil extracts of the test article met the requirements of the Intracutaneous injection test in rabbit according to the procedures described in the ISO 10993-10 standard.
All testing passed.
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Performance Testing
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
Dynamic
The dynamic test was conducted to evaluate the fatigue resistance of the bone punches following 12.500 cutting simulations. The testing confirmed the integrity of both the predicate device and the Fehling-Punches.
Static
Performance testing was conducted to evaluate the cutting displacement in relation to the manual force applied for both the subject and predicate device. Testing confirmed that the mean force required to operate the subject device is comparable to that of the predicate device.
Engineering Analysis
- -An engineering analysis of the Fehling-Punches and the Integra Kerrison Rongeurs was conducted to compare the design principles, dimensional characteristics, materials and mode of operation. Analysis showed that the subject and predicate devices are substantially equivalent in all of these parameters.
Cleaning - and Sterilization Validation
Fehling Instruments has successfully performed an automated cleaning validation according TIR 30 Technical report and a sterilization according to ISO 17665 Standards and AAMI TIR 12 Technical report- Full cycle 132°C and 4 minutes.
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510(k) Premarket Notification
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| Test | Test Method | Results |
|---|---|---|
| AutomatedCleaningvalidation | Automated Cleaning Effectiveness Study of theCERAMO Bone Punch according to AAMI TIR 30technical report | Automated cleaningwas validated |
| Sterilizationvalidation | Validation of the Steam Sterilization in a Pre-VacuumAir Removal Autoclave according to the ISO 17665Standards and AAMI TIR 30 technical report - Fullcycle 132°C and 4 min | Sterilization processwas validated |
| Cytotoxicity test | ISO MTS cytotoxicity test | Non-cytotoxic |
| Irritation test | ISO Intracutaneous Study in Rabbits - Two Extracts | Non-irritant |
| Toxicity test | ISO Acute Systemic Toxicity Study in Mice - TwoExtracts | Non-toxic |
| Hemolysis test | ISO 10993 and ASTM Hemolysis | Non- hemolytic |
| Pyrogenity test | USP - Rabbit Pyrogen Study according to UnitedStates Pharmacopeia 38 - National Formulary 33(USP) | Non-pyrogenic fordevices that haveundergone validatedcleaning andsterilization. |
| Sensitizationtest | ISO Guinea Pig Maximization Sensitization Test - TwoExtracts | Non- sensitizer |
| LAL-Test | Bacterial endotoxin quantification - LAL chromogenicmethod according to the European and AmericanPharmacopeia | Non-pyrogenic fordevices that haveundergone validatedcleaning andsterilization. |
| Coatingthicknessverification | Determination of coating thickness on bone puncheswith an electron microscope | It was verified that thecoating thickness ofFEHLING bonepunches is present onall relevant surfaceareas of the deviceand the layer lies in arange that ensuresthat all advantages ofthe coating are given. |
| DimensionalVerification | Dimensional Verification Test according to the actualspecifications of the bone punches | The dimensional andfunctionalspecifications of thedevices were verified. |
| Performancetesting | Performance Tests according to defined parametersdescribing worst case of use and extended use. | The devices passedthe tests. Onedeviation occurs, butwas probably due tomisplacement of theprobe |
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9. Clinical Performance Data
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device.
10. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
lt has been shown in this 510(k) submission that the difference between the Fehling Punches and the predicate devices do not raise any questions regarding safety and effectiveness.
Performance testing and compliance with voluntary standards, demonstrate that the Fehling Punches are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.
The Fehling Punches are determined to be substantially equivalent to the referenced predicate devices.
§ 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).