Fehling-Punches

K153243 · Fehling Instruments GmbH & Co. KG · HAE · Aug 4, 2016 · Neurology

Device Facts

• Record ID: K153243
• Device Name: Fehling-Punches
• Applicant: Fehling Instruments GmbH & Co. KG
• Product Code: HAE · Neurology
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

Device Story

Fehling Punches are reusable, manually operated stainless steel surgical instruments; used for cutting or biting bone during skull or spinal column surgery. Instruments feature various bite sizes (0.8-8 mm), jaw openings, and shaft configurations; coated with CERAMO (AlTiN) for durability. Operated by surgeons in clinical settings; no electrical or automated components. Device functions via mechanical force applied by the user to the handle, driving a sliding shaft against a fixed shaft to cut bone. Benefits include precise bone removal during neurosurgical or orthopedic procedures. Output is the physical removal of bone tissue. Reusable design requires cleaning and steam sterilization between uses.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, hemolysis, systemic toxicity, intracutaneous study), fatigue resistance (12,500 cycles), cutting force analysis, and cleaning/sterilization validation.

Technological Characteristics

Materials: Stainless steel (ASTM F899), CERAMO (AlTiN) coating, silicone. Manual, non-electrical, reusable rongeur. Dimensions: 110-400 mm shaft length, 0.8-8 mm bite size. Sterilization: Steam (132°C, 4 min) per ISO 17665 and AAMI TIR 12. Cleaning: Automated washer-disinfector per AAMI TIR 30.

Indications for Use

Indicated for cutting or biting bone during surgery involving the skull or spinal column. No specific patient population, age, or gender restrictions provided.

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 (Jarit, Ruggles-Redmond, Miltex, MeisterHand) Kerrison Rongeurs (K150428)
• Integra (Jarit, Ruggles-Redmond, Miltex, MeisterHand) Kerrison Rongeurs (K092227)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: | [phone] |
|----------|------------------|
| Fax: | [phone] |
| Contact: | Mr. Arne Briest |

#### Date Prepared 2.

Date Prepared:

August 2, 2016

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Image /page/4/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, with a modern sans-serif font. The overall impression is one of professionalism and precision.

#### 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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Image /page/5/Picture/2 description: The image shows the words "FEHLING INSTRUMENTS" stacked on top of each other. The word "FEHLING" is in a larger font than the word "INSTRUMENTS". Both words are in a sans-serif font and are a light blue color. The words are aligned to the left.

#### 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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Image /page/6/Picture/2 description: The image shows the logo for "FEHLING INSTRUMENTS". The text is in a sans-serif font and is a light blue color. The word "FEHLING" is on the top line, and the word "INSTRUMENTS" is on the bottom line.

## 7. Substantial Equivalence Discussion

| | new device | Predicate<br>Integra (Kerrison<br>Rongeurs) | Predicate<br>Integra (Kerrison<br>Rongeurs) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>(bone punches) are<br>manually operated<br>instruments<br>indicated for cutting<br>or biting bone during<br>surgery involving the<br>skull or spinal<br>column. | Integra Kerrison<br>Rongeurs are manually<br>operated instruments<br>indicated for cutting or<br>biting bone during<br>surgery involving the<br>skull or spinal column. | Integra Kerrison<br>Rongeurs are manually<br>operated instruments<br>indicated for cutting or<br>biting bone during<br>surgery involving the<br>skull or spinal column. |
| Sterility | Non Sterile | Non Sterile | Non Sterile |
| Cleaning | Instrument can be<br>processed in a<br>validated washer-<br>disinfector prior<br>sterilization | Instrument can be<br>processed in a<br>validated washer-<br>disinfector prior<br>sterilization | Instrument can be<br>processed in a<br>validated washer-<br>disinfector prior<br>sterilization |
| Material | 420 and 304<br>Stainless<br>Steels (ASTM F-<br>899);<br>Surface coatings:<br>CERAMO® (TiAIN);<br>Silicone | 420 Stainless steel<br>Surface coatings:<br>Titanium Nitride(TiN);<br>Diamond Coat and<br>Hard-Coat™ (TiAIN);<br>Stealth Coat and<br>Smooth-Coat™<br>(Dicronite DL-5);<br>Ultra-Coat™ (ZrN);<br>PTFE<br>(polytetrafluoroethylene<br>[Teflon®]);<br>Silicone (Elastosil®<br>LR3003/80 A,B) | medical grade<br>stainless steel (ASTM<br>F-899) |
| Design Features | Manual,<br>non-electrical,<br>non-sterile,<br>reusable,<br>non-malleable | Manual,<br>non-electrical,<br>non-sterile,<br>reusable,<br>non-malleable | Manual,<br>non-electrical,<br>non-sterile,<br>reusable,<br>non-malleable |
| | new device | Predicate<br>Integra (Kerrison<br>Rongeurs) | Predicate<br>Integra (Kerrison<br>Rongeurs) |
| Design | Rongeur with a<br>fixed and a sliding<br>shaft and angled<br>footplate Rongeur<br>with one fixed shaft,<br>one sliding shaft<br>and a mouthpart | Rongeur with a fixed<br>and a sliding shaft and<br>angled footplate<br>Rongeur with one fixed<br>shaft, one sliding shaft<br>and a mouthpart | Rongeur with a fixed<br>and a sliding shaft and<br>angled footplate<br>Rongeur with one fixed<br>shaft, one sliding shaft<br>and a mouthpart |
| Tip | Scoop-shaped tip,<br>various angles and<br>sizes (see below) | Scoop-shaped tip,<br>various angles and<br>sizes (see below) | Scoop-shaped tip,<br>various angles and<br>sizes |
| Shaft length | 110 - 400 mm | 4.75 - 15"<br>(approximately<br>121 mm - 381 mm) | 4.75 - 15"<br>(approximately<br>121 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 |
| Cutting<br>angulation | 40° and 90°<br>up/down | 40° and 90° up/down | 40° and 90° up/down |

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Image /page/7/Picture/2 description: The image shows the logo for Fehling Instruments. The text is in a light blue color. The word "FEHLING" is on the top line, and the word "INSTRUMENTS" is on the bottom line.

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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Image /page/8/Picture/2 description: The image shows the logo for "FEHLING INSTRUMENTS". The text is in a sans-serif font and is a light blue color. The word "FEHLING" is on the top line, and the word "INSTRUMENTS" is on the bottom line.

#### 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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Image /page/9/Picture/2 description: The image contains the text "FEHLING INSTRUMENTS" in a sans-serif font. The word "FEHLING" is on the top line, and the word "INSTRUMENTS" is on the bottom line. Both lines of text are in the same light blue color. The text appears to be a logo or brand name.

#### 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

Image /page/10/Picture/2 description: The image shows the logo for "FEHLING INSTRUMENTS". The text is in a sans-serif font and is a light blue color. The word "FEHLING" is on the top line, and the word "INSTRUMENTS" is on the bottom line.

| Test | Test Method | Results |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automated<br>Cleaning<br>validation | Automated Cleaning Effectiveness Study of the<br>CERAMO Bone Punch according to AAMI TIR 30<br>technical report | Automated cleaning<br>was validated |
| Sterilization<br>validation | Validation of the Steam Sterilization in a Pre-Vacuum<br>Air Removal Autoclave according to the ISO 17665<br>Standards and AAMI TIR 30 technical report - Full<br>cycle 132°C and 4 min | Sterilization process<br>was 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 - Two<br>Extracts | Non-toxic |
| Hemolysis test | ISO 10993 and ASTM Hemolysis | Non- hemolytic |
| Pyrogenity test | USP - Rabbit Pyrogen Study according to United<br>States Pharmacopeia 38 - National Formulary 33<br>(USP) | Non-pyrogenic for<br>devices that have<br>undergone validated<br>cleaning and<br>sterilization. |
| Sensitization<br>test | ISO Guinea Pig Maximization Sensitization Test - Two<br>Extracts | Non- sensitizer |
| LAL-Test | Bacterial endotoxin quantification - LAL chromogenic<br>method according to the European and American<br>Pharmacopeia | Non-pyrogenic for<br>devices that have<br>undergone validated<br>cleaning and<br>sterilization. |
| Coating<br>thickness<br>verification | Determination of coating thickness on bone punches<br>with an electron microscope | It was verified that the<br>coating thickness of<br>FEHLING bone<br>punches is present on<br>all relevant surface<br>areas of the device<br>and the layer lies in a<br>range that ensures<br>that all advantages of<br>the coating are given. |
| Dimensional<br>Verification | Dimensional Verification Test according to the actual<br>specifications of the bone punches | The dimensional and<br>functional<br>specifications of the<br>devices were verified. |
| Performance<br>testing | Performance Tests according to defined parameters<br>describing worst case of use and extended use. | The devices passed<br>the tests. One<br>deviation occurs, but<br>was probably due to<br>misplacement of the<br>probe |

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Image /page/11/Picture/2 description: The image shows the logo for "FEHLING INSTRUMENTS". The text is in a light blue color. The word "FEHLING" is on the top line, and the word "INSTRUMENTS" is on the bottom line.

#### 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.