(269 days)
Not Found
No
The device is a manually operated surgical instrument with no mention of software, algorithms, or data processing capabilities.
No.
The device is a surgical instrument used for cutting or biting bone, which is an interventional procedure rather than a therapeutic one. It facilitates treatment but does not itself provide therapy.
No
Explanation: The device is described as a surgical instrument for cutting or biting bone, not for diagnosing medical conditions. It performs a physical action (cutting bone) rather than analyzing patient data or images to identify a health issue.
No
The device description clearly states it is a reusable stainless steel instrument, which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Fehling rongeurs are "manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column." This describes a surgical instrument used directly on a patient's body during a procedure.
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical surgical tool made of stainless steel with specific features for cutting bone. It does not mention any components or functions related to analyzing biological samples.
Therefore, the Fehling rongeurs fall under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.
Product codes (comma separated list FDA assigned to the subject device)
HAE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull or 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)
Biocompatibility:
- 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 guinea 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 guinea 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 biocompatibility testing passed.
Performance Testing:
- 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.
- Automated Cleaning validation: Automated cleaning was validated.
- Sterilization validation: Sterilization process was validated.
Other Tests:
- Cytotoxicity test: Non-cytotoxic
- Irritation test: Non-irritant
- Toxicity test: Non-toxic
- Hemolysis test: Non-hemolytic
- Pyrogenity test: Non-pyrogenic for devices that have undergone validated cleaning and sterilization.
- Sensitization test: Non-sensitizer
- LAL-Test: Non-pyrogenic for devices that have undergone validated cleaning and sterilization.
- Coating thickness verification: It was verified that the coating thickness of FEHLING bone punches is present on all relevant surface areas of the device and the layer lies in a range that ensures that all advantages of the coating are given.
- Dimensional Verification: The dimensional and functional specifications of the devices were verified.
- Performance testing: The devices passed the tests. One deviation occurs, but was probably due to misplacement of the probe.
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is positioned to the right of a circular seal that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
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,
| 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
2
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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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
Integra (Kerrison
Rongeurs) | Predicate
Integra (Kerrison
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
(bone punches) are
manually operated
instruments
indicated for cutting
or biting bone during
surgery involving the
skull or spinal
column. | Integra Kerrison
Rongeurs are manually
operated instruments
indicated for cutting or
biting bone during
surgery involving the
skull or spinal column. | Integra Kerrison
Rongeurs are manually
operated instruments
indicated for cutting or
biting bone during
surgery involving the
skull or spinal column. |
| Sterility | Non Sterile | Non Sterile | Non Sterile |
| Cleaning | Instrument can be
processed in a
validated washer-
disinfector prior
sterilization | Instrument can be
processed in a
validated washer-
disinfector prior
sterilization | Instrument can be
processed in a
validated washer-
disinfector prior
sterilization |
| Material | 420 and 304
Stainless
Steels (ASTM F-
899);
Surface coatings:
CERAMO® (TiAIN);
Silicone | 420 Stainless steel
Surface coatings:
Titanium Nitride(TiN);
Diamond Coat and
Hard-Coat™ (TiAIN);
Stealth Coat and
Smooth-Coat™
(Dicronite DL-5);
Ultra-Coat™ (ZrN);
PTFE
(polytetrafluoroethylene
[Teflon®]);
Silicone (Elastosil®
LR3003/80 A,B) | medical grade
stainless steel (ASTM
F-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 | Predicate
Integra (Kerrison
Rongeurs) | Predicate
Integra (Kerrison
Rongeurs) |
| Design | Rongeur with a
fixed and a sliding
shaft and angled
footplate Rongeur
with one fixed shaft,
one sliding shaft
and a mouthpart | Rongeur with a fixed
and a sliding shaft and
angled footplate
Rongeur with one fixed
shaft, one sliding shaft
and a mouthpart | Rongeur with a fixed
and a sliding shaft and
angled footplate
Rongeur with one fixed
shaft, one sliding shaft
and a mouthpart |
| Tip | Scoop-shaped tip,
various angles and
sizes (see below) | Scoop-shaped tip,
various angles and
sizes (see below) | Scoop-shaped tip,
various angles and
sizes |
| Shaft length | 110 - 400 mm | 4.75 - 15"
(approximately
121 mm - 381 mm) | 4.75 - 15"
(approximately
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
angulation | 40° and 90°
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.
9
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.
10
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 | ||
| Cleaning | ||
| validation | Automated Cleaning Effectiveness Study of the | |
| CERAMO Bone Punch according to AAMI TIR 30 | ||
| technical report | Automated cleaning | |
| was validated | ||
| Sterilization | ||
| validation | Validation of the Steam Sterilization in a Pre-Vacuum | |
| Air Removal Autoclave according to the ISO 17665 | ||
| Standards and AAMI TIR 30 technical report - Full | ||
| cycle 132°C and 4 min | Sterilization process | |
| 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 | |
| Extracts | Non-toxic | |
| Hemolysis test | ISO 10993 and ASTM Hemolysis | Non- hemolytic |
| Pyrogenity test | USP - Rabbit Pyrogen Study according to United | |
| States Pharmacopeia 38 - National Formulary 33 | ||
| (USP) | Non-pyrogenic for | |
| devices that have | ||
| undergone validated | ||
| cleaning and | ||
| sterilization. | ||
| Sensitization | ||
| test | ISO Guinea Pig Maximization Sensitization Test - Two | |
| Extracts | Non- sensitizer | |
| LAL-Test | Bacterial endotoxin quantification - LAL chromogenic | |
| method according to the European and American | ||
| Pharmacopeia | Non-pyrogenic for | |
| devices that have | ||
| undergone validated | ||
| cleaning and | ||
| sterilization. | ||
| Coating | ||
| thickness | ||
| verification | Determination of coating thickness on bone punches | |
| with an electron microscope | It was verified that the | |
| coating thickness of | ||
| FEHLING bone | ||
| punches is present on | ||
| all relevant surface | ||
| areas of the device | ||
| and the layer lies in a | ||
| range that ensures | ||
| that all advantages of | ||
| the coating are given. | ||
| Dimensional | ||
| Verification | Dimensional Verification Test according to the actual | |
| specifications of the bone punches | The dimensional and | |
| functional | ||
| specifications of the | ||
| devices were verified. | ||
| Performance | ||
| testing | Performance Tests according to defined parameters | |
| describing worst case of use and extended use. | The devices passed | |
| the tests. One | ||
| deviation occurs, but | ||
| was probably due to | ||
| misplacement of the | ||
| 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.