(85 days)
Not Found
No
The device description and performance studies focus on mechanical components and physical testing, with no mention of AI or ML.
No
Explanation: This device is used for obtaining diagnostic tissue samples, not for treating or curing a medical condition.
No
This device is used to obtain tissue samples, but it does not analyze or interpret those samples to provide a diagnosis. The diagnostic process would occur separately after the tissue is obtained.
No
The device description clearly outlines physical components (actuating handle, flexible shaft, stainless steel cutting jaws) and performance studies related to material properties and mechanical function, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The FEHLING biopsy forceps are a surgical instrument used to obtain a tissue sample from the heart. They are used in vivo (within the living body) to collect the specimen.
- Lack of Diagnostic Testing: The device itself does not perform any diagnostic testing on the collected tissue. The tissue sample obtained by the forceps would then be sent to a laboratory for in vitro diagnostic testing (e.g., histology, pathology).
Therefore, the FEHLING biopsy forceps are a surgical device used for tissue collection, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right and left ventricle
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
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 externally communicating devices with limited contact (
§ 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).
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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
1
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
2
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)
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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 BIOPSY
FORCEP | T-REX™ Biopsy | Substantial
Equivalence |
|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 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 Forceps
Bioptome (subject
device) | MYOCARD BIOPSY
FORCEP | T-REX™ Biopsy | Substantial
Equivalence |
| Manufacturer | FEHLING
INSTRUMENTS
GmbH & Co. KG | FEHLING
INSTRUMENTS
GmbH & Co. KG | Boston Scientific
Corporation Northwest
Technology Center,
Inc. | |
| Indication for
Use | FEHLING biopsy
forceps are used to
obtain
endomyocardial
biopsy specimens
from the right and left
ventricle via
percutaneous arterial
or venous approach. | The Fehling
Myocardial Biopsy
Forceps are intended
for use in ventricular
endomyocardial biopsy | The T-REX biopsy
forceps is used to
obtain endomyocardial
biopsy specimens from
the right and left
ventricle via
percutaneous arterial
or 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 | Proprietary
sharpening method | Proprietary sharpening
method | Proprietary sharpening
method | Identical |
| Actuator links | Hardened stainless
steel | Hardened stainless
steel | Hardened stainless
steel | Identical |
| Actuator/ pull
wire
connection | Laser Welded | Laser Welded | Laser Welded | Identical |
| Housing | Slotted jacket | Slotted jacket | Laser welded housing
halves | Similar |
| Housing to
outer Jacket
Connection | 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 of
Shaft | 510 mm
800 mm
1000 mm
1200 mm | 510 mm
800 mm
1000 mm
1200 mm | - | Identical
(additional
1200 mm
length
offering for
2.2 mm jaws) |
| Attachment of
actuator/
actuator links
and
jaws/housing | Captured by slotted
jacket | Captured by slotted
jacket | Captured by laser
welded housing halves | Similar |
| Body | | | | |
| Pull Wire | Solid Stainless Steel
Wire | Solid Stainless Steel
Wire | Solid Stainless Steel
Wire | Identical |
| Shape | Flexible | Flexible | Flexible and pre-
curved | Similar |
| Liner | --- | --- | Liner between outer
jacket and pull wire | Identical |
| Jacket sheath | Jacket sheath
covering the outer
jacket | Jacket sheath covering
the outer jacket | Jacket sheath covering
the outer jacket | Similar |
| Handle Assembly | | | | |
| Handle
transition to
outer jacket | Crimped joint with
internal rope | Crimped joint with
internal rope | Crimped joint with
integral strain relief | Similar |
| Handle
transition to
handle body | Plastic handle
transition press fit into
tapered handle body | Plastic handle
transition press fit into
tapered handle body | Stainless steel handle
transition press fit into
tapered handle body | Similar |
| Finger Grip /
Handle body | Pusher for holding
jaws open during
specimen | Pusher for holding
jaws open during
specimen | Locking feature for
holding jaws open
during specimen
removal | Similar |
| Finger grip
insert for
attachment of
pull 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 |
| Product
Holder | Blister Package | Blister Package | Coil or Card | Similar |
| Similar basic design and shape, fitting the indication, dimensions are adjusted accordingly | | | | |
5
6
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
7
externally communicating devices with limited contact (