(116 days)
Not Found
No
The description focuses on the mechanical and electrical functions of a biopsy forceps and does not mention any AI or ML components.
Yes
The device is used to cauterize and remove polyps and tissue specimens, which are direct medical interventions for treating conditions in the alimentary tract.
No
Explanation: The device is intended for therapeutic purposes (cauterizing and removing polyps/tissue) rather than for diagnosing conditions or diseases.
No
The device description clearly outlines a physical medical device (forceps) with mechanical and electrical components for cauterization and tissue removal. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cauterize and remove polyps and/or tissue specimens" from the alimentary tract. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a tool for physically manipulating and removing tissue, with the added function of cauterization. It does not perform any analysis of biological samples in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing tissue samples, detecting biomarkers, or providing diagnostic information based on the removed tissue. The focus is on the removal process itself.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) to perform a procedure.
N/A
Intended Use / Indications for Use
These Single-Use Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract. The alimentary tract includes the esophagus, stomach, duodenum, jejunum, ileum and colon.
Product codes
KGE
Device Description
The Radial Jaw™ 4 Hot Biopsy Forceps (RJ4 Hot) are sterile, single-use devices. The Radial Jaw" 11 Hot Biopsy Forceps have a jaw size compatible with a 2.8mm or larger working channel endoscope and are available with a 240cm working length.
The RJ4 Hot device provides the user the ability to cauterize via an electrical current passed through the device from an electrosurgical generator. The generator is attached to the connector located in the spool. The connector contacts the dual pull wires, which provides an electrical path to the jaws of the device.
To open and close the jaws the user slides the spool back and forth over the handle body. Using the RJ4 Hot device the user can cauterize and remove polyps by opening the jaws, pressing the jaws against the tissue site, closing the jaws, applying an electrical current through the connector and pulling the jaws away from the tissue site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract (esophagus, stomach, duodenum, jejunum, ileum, and colon)
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)
Bench testing and Electrical Safety Testing have been performed on the finished Radial Jaw™ 4 Hot Biopsy Forceps device per the direction of the Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology. Bench testing and Electrical Safety Testing demonstrated that the proposed device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
KL101687
SECTION 6 510(k) SUMMARY
- Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4359 Fax: 508-683-5939
Contact: Ashley Pyle Sr. Regulatory Affairs Specialist Date Prepared: June 7, 2010
2. Proposed Device:
Trade Name: Radial Jaw™ 4 Hot Biopsy Forceps Classification Name: Forceps, Biopsy, Electric Regulation Number: 876.4300 Product Code: KGE Classification: Class II
3. Predicate Device:
Boston Scientific Radial Jaw" Hot Biopsy Forceps (K910964) Boston Scientific Radial Jaw Th 3 Hot Biopsy Forceps (K910964) Olympus Disposable Hot Biopsy Forceps (K955052)
4. Proposed Device Description:
The Radial Jaw™ 4 Hot Biopsy Forceps (RJ4 Hot) are sterile, single-use devices. The Radial Jaw" 11 Hot Biopsy Forceps have a jaw size compatible with a 2.8mm or larger working channel endoscope and are available with a 240cm working length.
The RJ4 Hot device provides the user the ability to cauterize via an electrical current passed through the device from an electrosurgical generator. The generator is attached to the connector located in the spool. The connector contacts the dual pull wires, which provides an electrical path to the jaws of the device.
To open and close the jaws the user slides the spool back and forth over the handle body. Using the RJ4 Hot device the user can cauterize and remove polyps by opening the jaws, pressing the jaws against the tissue site, closing the jaws, applying an electrical current through the connector and pulling the jaws away from the tissue site.
OCT - 5 2010
1
5. Intended Use/ Indications for Use:
These Single-Use Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract. The alimentary tract includes the esophagus, stomach, duodenum, jejunum, ileum and colon.
6. Technological Characteristics:
The proposed Radial Jaw™ 4 Hot Biopsy Forceps are nearly identical in design, materials, and manufacturing processes to the predicate Radial Jaw 10 Hot Biopsy Forceps (K910964), Radial Jaw'll 3 Hot Biopsy Forceps (K910964) and the Olympus Disposable Hot biopsy Forceps (K955052).
7. Performance Data:
Bench testing and Electrical Safety Testing have been performed on the finished Radial Jaw™ 4 Hot Biopsy Forceps device per the direction of the Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology. Bench testing and Electrical Safety Testing demonstrated that the proposed device is substantially equivalent to the predicate devices.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Radial Jawns 4 Hot Biopsy Forceps are substantially equivalent to Boston Scientific Corporation's currently marketed Radial Jaw" Hot Biopsy Forceps (K910964), Radial Jaw 3 Hot Biopsy Forceps (K910964) the Olympus Disposable Hot Biopsy Forceps (K955052).
2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Ashley Pyle Sr. Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
OCT 5 2010
Re: K101657
Trade/Device Name: Radial Jaw 4 Hot Biopsy Forceps Models: M00515031, M00515032 and M00515033 Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: September 6, 2010 Received: September 8, 2010
Dear Ms. Pyle:
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 of medical device-related
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default:htm.
Sincerely yours,
Hubert Lewin MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 5 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): To Be Determined
Device Name: Radial Jaw 4 Hot Biopsy Forceps
Indications for Use:
Prescription Use
X
These Single-Use Biopsy Forceps are intended to be used through an endoscope to cauterize polyps and/or tissue specimens throughout the alimentary tract. The alimentary tract include the esophagus, stomach, duodenum, jejunum, ileum, and colon.
| (Part 21 CFR 801 Part D) | (21 CFR 807 Subpart C) |
|---|---|
| -------------------------- | ------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K101657 |
Abbreviated 510(k) Premarket Notification, Radial Jaw
TM 4 Hot Biopsy Forceps
AND/OR
Proprietary and Confidential Information of Boston Scientific Corporation
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Over-The-Counter Use