(85 days)
FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.
The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components:
- an actuating handle ergonomically designed for comfortable use, 1.
-
- a flexible shaft,
- and surgical stainless steel cutting jaws. 3.
At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device.
The product is provided single for use and sterile.
The provided document is a 510(k) premarket notification for a medical device called "Biopsy Forceps." It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. The document includes non-clinical performance data to support its claims but does not include details about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML devices (e.g., performance metrics like accuracy, sensitivity, specificity).
Instead, the document focuses on demonstrating physical and biological compatibility and functionality for a mechanical medical device. Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
Here's an attempt to answer the questions based only on the provided text, recognizing the limitations:
1. A table of acceptance criteria and the reported device performance
The document states that "All samples passed the test and met the acceptance criteria" for several non-clinical tests, but it does not explicitly define those acceptance criteria. The reported "performance" is simply that the device met these (unspecified) criteria.
| Test Type | Acceptance Criteria (Not Explicitly Defined) | Reported Device Performance |
|---|---|---|
| Dimensional Verification Tests | Not explicitly defined | All samples passed the test |
| Tensile Tests | Not explicitly defined | All samples passed the test |
| Simulation Test (Insertion & Tissue Samples) | Not explicitly defined | All samples passed the test |
| Shelf Life Testing & Transport Simulation | Not explicitly defined | All samples passed the test |
| Biocompatibility (ISO 10993-1) | Not explicitly defined | Meets ISO 10993-1 requirements |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "All samples" for the dimensional, tensile, and shelf life tests, but it does not specify the exact number of samples.
For the Simulation Test - Insertion and Taking of Tissue Samples:
- Sample Size: "The process was repeated 10 times per device." The number of devices used is not specified.
- Data Provenance: No country of origin or retrospective/prospective nature is specified for the non-clinical tests. The tissue samples were "fresh porcine heart specimens."
For Biocompatibility: "The full strength EMEM10 test article showed no cytotoxic potential to L-929 mouse fibroblast cells." No specific sample size (number of cells or test articles) is given, beyond indicating "the test article."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML study requiring expert consensus for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device.
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 a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm. The performance tests ("Dimensional Verification," "Tensile Tests," "Simulation Test - Insertion and Taking of Tissue Samples," "Shelf Life Testing") are effectively "standalone" tests of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests:
- Dimensional Verification: Comparison to engineering specifications/manufacturing tolerances (implied).
- Tensile Tests: Comparison to mechanical strength specifications (implied).
- Simulation Test: Successful introduction and harvesting of tissue samples from "fresh porcine heart specimens" (functional verification).
- Shelf Life Testing: Maintenance of specified performance after accelerated aging/transport simulation.
- Biocompatibility: Results from standardized cytotoxicity, chemical characterization, and previous toxicological data compared against ISO 10993-1 requirements.
8. The sample size for the training set
Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a non-clinical, mechanical/biological performance study for a physical device, not an AI/ML algorithm.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
Fehling Instruments GmbH & Co. KG % Arne Briest CEO VISAMED GmbH Kastellstr. 8 D-76227 Karlsruhe Germany
Re: K170726
Trade/Device Name: Biopsy Forceps Regulation Number: 21 CFR 870.4075 Regulation Name: Endomyocardial Biopsy Device Regulatory Class: Class II Product Code: DWZ Dated: March 6, 2017 Received: March 9, 2017
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
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
M.A. Hillebrand
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170726
Device Name Biopsy Forceps
Indications for Use (Describe)
FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 |
2. Date Prepared
Date Prepared:
May 15, 2017
3. Device Identification
Trade/Proprietary Name: Biopsy Forceps Device: Device, Biopsy, Endomyocardial Regulation Description: Endomyocardial biopsy device Classification Regulation 21 CFR 870.4075 Product Code: DWZ Device Class: Class 2 Classification Panel Cardiovascular
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4. Legally Marketed Predicate Devices
Primary Predicate:
K973818 - Boston Scientific Corporation Northwest Technology Center, Inc.; T-REX ™- Biopsy foreceps, cleared December 16, 1997
Additional Predicate:
K881412 - Fehling Medizintechnik GmbH, Myocard Biopsy Forcep, cleared September 8, 1988
5. Device Description
The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components:
- an actuating handle ergonomically designed for comfortable use, 1.
-
- a flexible shaft,
- and surgical stainless steel cutting jaws. 3.
At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device.
The product is provided single for use and sterile.
6. Indications for Use
FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.
7. Substantial Equivalence Discussion
The Biopsy Forceps have the same intended use, similar performance characteristics, are manufactured from similar materials and are similar in design to the predicate devices.
The Biopsy Forceps are identical in design, material and intended to the previously cleared Biopsy Forceps by Fehling.
| Biopsy Forceps(subject device) | MYOCARD BIOPSYFORCEP | T-REX™ Biopsy | SubstantialEquivalence | |
|---|---|---|---|---|
| 510k Reference | (subject device) | K881412 | K973818 | - |
| Product Code | DWZ | DWZ | DWZ | Identical |
| Regulation # | 870.4075 | 870.4075 | 870.4075 | Identical |
| Class | II | II | II | Identical |
| Biopsy ForcepsBioptome (subjectdevice) | MYOCARD BIOPSYFORCEP | T-REX™ Biopsy | SubstantialEquivalence | |
| Manufacturer | FEHLINGINSTRUMENTSGmbH & Co. KG | FEHLINGINSTRUMENTSGmbH & Co. KG | Boston ScientificCorporation NorthwestTechnology Center,Inc. | |
| Indication forUse | FEHLING biopsyforceps are used toobtainendomyocardialbiopsy specimensfrom the right and leftventricle viapercutaneous arterialor venous approach. | The FehlingMyocardial BiopsyForceps are intendedfor use in ventricularendomyocardial biopsy | The T-REX biopsyforceps is used toobtain endomyocardialbiopsy specimens fromthe right and leftventricle viapercutaneous arterialor venous approach. | Similar |
| Sterility | Sterile | Sterile | Sterile | Identical |
| Sterilization | ETO, SAL 10-6 | ETO, SAL 10-6 | ETO, SAL 10-6 | Identical |
| Utility | Single Use | Single Use | Single Use | Identical |
| End-Effector and Jaw Assembly | ||||
| Jaws | Proprietarysharpening method | Proprietary sharpeningmethod | Proprietary sharpeningmethod | Identical |
| Actuator links | Hardened stainlesssteel | Hardened stainlesssteel | Hardened stainlesssteel | Identical |
| Actuator/ pullwireconnection | Laser Welded | Laser Welded | Laser Welded | Identical |
| Housing | Slotted jacket | Slotted jacket | Laser welded housinghalves | Similar |
| Housing toouter JacketConnection | Laser Welded | Laser Welded | Laser welded | Identical |
| Crank length /lever angle | 1.6mm jaws;1.8mm jaws;2.2mm jaws; | 1.6mm jaws;1.8mm jaws;2.2mm jaws; | 1.8mm jaws;2.2mm jaws;15° | Similar |
| Length ofShaft | 510 mm800 mm1000 mm1200 mm | 510 mm800 mm1000 mm1200 mm | - | Identical(additional1200 mmlengthoffering for2.2 mm jaws) |
| Attachment ofactuator/actuator linksandjaws/housing | Captured by slottedjacket | Captured by slottedjacket | Captured by laserwelded housing halves | Similar |
| Body | ||||
| Pull Wire | Solid Stainless SteelWire | Solid Stainless SteelWire | Solid Stainless SteelWire | Identical |
| Shape | Flexible | Flexible | Flexible and pre-curved | Similar |
| Liner | --- | --- | Liner between outerjacket and pull wire | Identical |
| Jacket sheath | Jacket sheathcovering the outerjacket | Jacket sheath coveringthe outer jacket | Jacket sheath coveringthe outer jacket | Similar |
| Handle Assembly | ||||
| Handletransition toouter jacket | Crimped joint withinternal rope | Crimped joint withinternal rope | Crimped joint withintegral strain relief | Similar |
| Handletransition tohandle body | Plastic handletransition press fit intotapered handle body | Plastic handletransition press fit intotapered handle body | Stainless steel handletransition press fit intotapered handle body | Similar |
| Finger Grip /Handle body | Pusher for holdingjaws open duringspecimen | Pusher for holdingjaws open duringspecimen | Locking feature forholding jaws openduring specimenremoval | Similar |
| Finger gripinsert forattachment ofpull wire | Plastic (POM) | Plastic (POM) | Aluminum / Press fit | Similar |
| Handle Spring | 20mm coil spring | 20mm coil spring | 12,7 mm Spring coil | Similar |
| Package | ||||
| Configuration | Single Barrier | Single Barrier | Single Barrier | Similar |
| ProductHolder | Blister Package | Blister Package | Coil or Card | Similar |
| Similar basic design and shape, fitting the indication, dimensions are adjusted accordingly |
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8. Non-Clinical Performance Data
Biocompatibility
Biocompatibility testing on the Fehling-Biopsy Forceps was conducted and evaluated per ISO 10993-1.
Cytotoxicity
The full strength EMEM10 test article showed no cytotoxic potential to L-929 mouse fibroblast cells.
Chemical Characterization
The Biopsy Forceps, were exhaustively extracted in Purified Water, Ethanol, and Hexane. The resulting extracts were analyzed by Fourier Transform Infrared Spectroscopy (FTIR) and Gas Chromatography (GC-MS). The ethanol and hexane test extracts were analyzed by Ultra Performance Liquid Chromatography - Mass Spectroscopy (UPLC-MS). The purified water test extract was analyzed by Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES) and lon Chromatography.
Conclusion:
The biological risk assessment performed was supported by information on the Biopsy Forceps materials of construction, gathered toxicological data on these materials, available chemical characterization and biological data on Biopsy Forceps. This information and related analysis provides the evidence required to conclude that additional biocompatibility testing is not needed. The Biopsy Forceps therefore meets the requirements of ISO 10993-1 and 2016 FDA Guidance for
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externally communicating devices with limited contact (<24 hours) with circulating blood and can be considered biocompatible for use.
Non-Clinical Performance Testing
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices.
Dimensional Verification Tests
Dimensional verification testing was performed to evaluate the Biopsy Forceps.
All samples passed the test and met the acceptance criteria.
Tensile Tests
Tensile Tests on critical joints were performed on the Biopsy Forceps to evaluate the mechanical stability of the product.
All samples passed the test and met the acceptance criteria.
Simulation Test - Insertion and Taking of Tissue Samples
The purpose of the test was to evaluate the introduction of the device to a worst case anatomical structure and to harvest tissue samples using fresh porcine heart specimens. The process was repeated 10 times per device.
All samples passed the test and met the acceptance criteria.
Shelf Life Testing and Transport Simulation
Shelf Life Testing and Transport Simulation testing was performed to support the shelf life of 5 years and the safe transport of the Biopsy Forceps.
All samples passed the test and met the acceptance criteria. The Biopsy Forceps have a shelf life of 5 years.
9. Clinical Performance Data
There was no clinical testing required to support the medical device.
10. Statement of Substantial Equivalence
The information presented in this 510(k) submission demonstrates that the differences between the Biopsy Forceps and the predicate devices do not raise any questions regarding safety and effectiveness.
Performance testing and compliance with voluntary standards demonstrate that the Fehling- Biopsy
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Forceps 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 Biopsy Forceps are determined to be substantially equivalent to the referenced predicate devices.
§ 870.4075 Endomyocardial biopsy device.
(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).