(126 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality, with no mention of AI or ML.
No
The device is described as disposable biopsy forceps used to obtain tissue samples for pathology. Its primary function is diagnostic (obtaining tissue for review), not therapeutic (treating a disease or condition).
Yes.
The device is used to obtain mucosal tissue samples for pathology, which is a diagnostic purpose.
No
The device description clearly outlines physical components like a handle, jaws, a sheath catheter, and an active cord connector, indicating it is a hardware device. The performance studies also focus on structural, dimensional, functional, and electrical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This examination is performed in vitro (outside the living body).
- Device Function: The described device is a disposable biopsy forceps used to obtain tissue samples from the living body (in the gastrointestinal tract) during an endoscopic procedure. While the tissue samples are then submitted for pathologic review (which is an in vitro process), the device itself is used in vivo (within the living body) to collect the sample.
The device's primary function is the mechanical and electrical removal of tissue from a patient, not the analysis or examination of a specimen outside the body.
N/A
Intended Use / Indications for Use
Disposable biopsy forceps are used to obtain mucosal tissue samples for pathology using monopolar energy, including the avulsion technique, during endoscopic procedures in the gastrointestinal tract, for example the esophagus, stomach, small intestine and colon. Tissue samples will be submitted for pathologic review.
This product is intended only for adult populations.
Product codes (comma separated list FDA assigned to the subject device)
KGE
Device Description
The Avulsion Forceps is used during endoscopic procedures in the gastrointestinal tract. The avulsion technique in Endoscopy involves using both mechanical forces as well as high energy cutting current to tear the tissue away from the gastrointestinal tract.
The Avulsion Forceps consists of a handle on the proximal end that actuates two toothed jaws on the distal end. An Olympus-style active cord connector is included that allows the Avulsion Forceps to be connected to an electrosurgical generator for use with monopolar energy. The device also includes a spring sheath catheter housing the drive cable which transfers the linear motion of the handle slider to open and close the jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, for example the esophagus, stomach, small intestine and colon.
Indicated Patient Age Range
adult populations.
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)
Table 5-2 summarizes the verification activities that were performed with respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the Avulsion Forceps device.
- Structural Integrity Testing: All Avulsion Forceps structural components must, minimally, meet or exceed the structural integrity limits by the predicate hot biopsy forceps. Result: PASS
- Dimensional: All Avulsion Forceps dimensional components must meet the dimensional specification for each forceps. Result: PASS
- Functional Testing: The Avulsion Forceps must function as intended in tortuous conditions. Result: PASS
- Simulation Testing: The Avulsion Forceps retrieve tissue samples. Result: PASS
- Electrical Testing: All Avulsion Forceps electrical requirements must meet current industry standards according to IEC 60601-2-2 (3rd Edition). Result: PASS
- Biocompatibility Testing: The patient contacting components of the device must be biologically safe to use in accordance with ISO-10993-1. Result: PASS
- Shelf Life: The Avulsion Forceps must maintain device performance through a shelf life of 1 year. Result: PASS
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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April 16, 2019
STERIS Corporation Eileen McCafferty Senior Regulatory Specialist 5960 Heisley Rd Mentor, OH 44060
Re:
K183428 Trade/Device Name: Avulsion Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KGE Dated: December 10, 2018 Received: December 11, 2018
Dear Eileen McCafferty:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
(for) Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183428
Device Name Avulsion Forceps
Indications for Use (Describe)
Disposable biopsy forceps are used to obtain mucosal tissue samples for pathology using monopolar energy, including the avulsion technique, during endoscopic procedures in the gastrointestinal tract, for example the esophagus, stomach, small intestine and colon. Tissue samples will be submitted for pathologic review.
This product is intended only for adult populations.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary For Avulsion Forceps
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Eileen McCafferty Contact: Senior Regulatory Affairs Specialist Tel: 440-392-7189 Fax: 440-357-9198 Email: eileen_mccafferty@steris.com
April 3, 2019 Summary Date:
Premarket Notification Number: K183428
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Avulsion Forceps |
|---|---|
| Device Classification: | Class II |
| Common/usual Name: | Electric Biopsy Forceps, Hot Biopsy Forceps |
| Classification Name: | Endoscopic Electrosurgical unit and accessories |
| Classification Number: | 21 CFR 876.4300 |
| Product Code: | KGE |
2. Predicate Device
US Endoscopy Disposable Hot Biopsy Forceps K925361
3. Description of Device
The Avulsion Forceps is used during endoscopic procedures in the gastrointestinal tract. The avulsion technique in Endoscopy involves using both mechanical forces as well as high energy cutting current to tear the tissue away from the gastrointestinal tract.
The Avulsion Forceps consists of a handle on the proximal end that actuates two toothed jaws on the distal end. An Olympus-style active cord connector is included that allows the Avulsion Forceps to be connected to an electrosurgical generator for use with monopolar energy. The device also includes a spring sheath catheter housing the drive cable which transfers the linear motion of the handle slider to open and close the jaws.
4. Intended Use/Indications for Use
Disposable biopsy forceps are used to obtain mucosal tissue samples for pathology using monopolar energy, including the avulsion technique, during endoscopic procedures in the gastrointestinal tract, for example the esophagus, stomach, small intestine and colon. Tissue samples will be submitted for pathologic review.
This product is intended only for adult populations.
5
ട്. Description of Technological Similarities and Differences
The US Endoscopy (USE) Avulsion Forceps are very similar to the USE Disposable Hot Biopsy Forceps in intended use and mode of operation. The major differences between the USE Avulsion Forceps and the USE Hot Biopsy Forceps include the indication for use in avulsion technique that the predicate did not have. However, this does not affect the intended use of the device as the intended use of each device is to resect tissue for removal and/or further diagnosis. The proposed and predicate devices have the same technological characteristics in that both devices use electrical energy and manual traction (pull force) to resect tissue. Avulsion is a resection technique that uses a different setting on the electrical surgical generator (Cut as opposed to Coagulation) and a different application of that energy (continuous flow as opposed to modulated flow). This change in technique does not affect the fact that the Avulsion forceps and its predicate both use manual traction and electrical energy to resect tissue for the purpose of removal and/or further diagnosis.
Also, the Avulsion Forceps use a single drive cable to control the jaws, whereas the predicate hot biopsy forceps use a dual drive cable system, and the Avulsion Forceps has a toothed cup while the predicate had a plain cup type. The difference in cup design has no effect on the intended use of the devices as both cup types can be used to grasp tissue and deliver current. These proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.
6. Description of Safety and Substantial Equivalence
Table 5-1 summarizes the difference between the proposed device and the predicate.
| Feature | Proposed
Avulsion Forceps | Predicate K925361/A
USE Disposable Hot
Biopsy Forceps | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use /
Indications for Use | Disposable biopsy forceps
are used to obtain mucosal
tissue samples for
pathology using
monopolar energy,
including the avulsion
technique, during
endoscopic procedures in
the gastrointestinal tract,
for example the
esophagus, stomach, small
intestine and colon. Tissue
samples will be submitted
for pathologic review. The | The US Endoscopy
Disposable hot biopsy
forceps are used to obtain
mucosal tissue samples
using monopolar energy
during endoscopic
procedures. | Proposed device
includes
indications for use
in avulsion
techniques.
Avulsion is a
resection
technique that uses
a different setting
on the electrical
surgical generator
(Cut as opposed to
Coagulation) and a
different |
| Feature | Proposed
Avulsion Forceps | Predicate K925361/A
USE Disposable Hot
Biopsy Forceps | Comparison |
| | product is intended only
for adult populations. | | application of that
energy
(continuous flow
as opposed to
modulated flow).
This change in
technique does not
affect the fact that
the Avulsion
Forceps and its
predicate both use
manual traction
and electrical
energy to resect
tissue for the
purpose of
removal and/or
further diagnosis. |
| Mode of Operation | Hand Control | Hand Control | Identical |
| Jaws Shape | Serrated
Image: Serrated Jaws | Oval
Image: Oval Jaws | The proposed
avulsion forceps
jaw design utilizes
toothed cups,
while the predicate
hot biopsy forceps
utilizes plain cups.
This difference
has no effect on
the intended use or
safety of the
devices as both
jaws are used to
grasp tissue and
deliver current. |
| Outer Tube
Diameter | $Φ$ 2.6 mm | $Φ$ 2.6 mm | Identical |
| Minimum Working
Channel | $Φ$ 2.8 mm | $Φ$ 2.8 mm | Identical |
| Working Length | 230 cm | 230 cm | Identical |
| Energy | Yes | Yes | Identical |
| Monopolar/Bipolar | Monopolar | Monopolar | Identical |
| Biocompatibility | Yes | Yes | Identical |
| Feature | Proposed
Avulsion Forceps | Predicate K925361/A
USE Disposable Hot
Biopsy Forceps | Comparison |
| Packaging | Sterile Tyvek pouch | Sterile Tyvek pouch | Identical |
| Disposable | Yes | Yes | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Accessories | None | None | Identical |
| Shelf-life | 1 year | 1 year | Identical |
Table 5-1. Predicate Device Comparison Table
6
STERIS Traditional 510(k) PREMARKET NOTIFICATION AVULSION FORCEPS
7
STERIS Traditional 510(k) PREMARKET NOTIFICATION AVULSION FORCEPS
Table 5-2 summarizes the verification activities that were performed with respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the Avulsion Forceps device.
| Table 5-2. Summary of Verification Activities. | ||
|---|---|---|
| Testing | Acceptance Criteria | Proposed Avulsion |
| Forceps | ||
| Structural | ||
| Integrity Testing | All Avulsion Forceps structural components | |
| must, minimally, meet or exceed the structural | ||
| integrity limits by the predicate hot biopsy | ||
| forceps | PASS | |
| Dimensional | All Avulsion Forceps dimensional components | |
| must meet the dimensional specification for | ||
| each forceps | PASS | |
| Functional | ||
| Testing | The Avulsion Forceps must function as | |
| intended in tortuous conditions | PASS | |
| Simulation | ||
| Testing | The Avulsion Forceps retrieve tissue samples | PASS |
| Electrical | ||
| Testing | All Avulsion Forceps electrical requirements | |
| must meet current industry standards according | ||
| to IEC 60601-2-2 (3rd Edition) | PASS | |
| Biocompatibility | ||
| Testing | The patient contacting components of the | |
| device must be biologically safe to use in | ||
| accordance with ISO-10993-1 | PASS |
7. Conclusion
Shelf Life for 12
months
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K925361), Class II (21 CFR 876.4300), product code KGE.
The Avulsion Forceps must maintain device
performance through a shelf life of 1 year
PASS