(28 days)
Not Found
No
The device description and performance studies focus solely on the mechanical function and design of a biopsy forceps, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is designed to collect tissue for diagnostic examination, not to treat a disease or condition.
Yes
The device is designed to collect tissue for "histologic examination," which is a diagnostic procedure used to identify diseases by examining tissue samples under a microscope.
No
The device description clearly describes a physical, sterile, single-use biopsy forceps with mechanical components (jaws, spool, pull wires) for tissue acquisition. It does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect tissue endoscopically for histologic examination." This describes a device used to obtain a sample from the body.
- Device Description: The description details a mechanical instrument for physically acquiring tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used to get the specimen, not to perform the diagnostic test on the specimen itself. The histologic examination (which is a diagnostic process) happens after the tissue is collected using this device.
Therefore, the Radial Jaw 4 Pulmonary Biopsy Forceps is a surgical or endoscopic instrument used for tissue collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.
Product codes
BWH
Device Description
The Radial Jaw 14 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use devices. The Radial Jaw'14 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length.
To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Bench Testing has been performed on the proposed Radial Jaw™ 4 Pulmonary Biopsy Forceps to demonstrate that the modified handle design met the required specifications for the completed tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
MAY 16 2012
SECTION 6 510(k) SUMMARY
K/21186
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Corrie Gooding Regulatory Affairs Specialist Telephone: 508-683-6643 Fax: 508-683-5939
Secondary Contact: Ashley Pyle Regulatory Affairs Manager Telephone: 508-683-4359 Fax: 508-683-5939
Date Prepared: April 17, 2012
2. Proposed Device:
Trade Name: Radial Jaw"N 4 Pulmonary Biopsy Forceps Classification Name: Bronchoscope (flexible or rigid) and accessories Regulation Number: 874.4680 Product Code: BWH Classification: Class II
3. Predicate Device:
Radial Jaw™ 4 Pulmonary Biopsy Forceps Manufacturer and Clearance Number: Boston Scientific Corp, K102336 Classification Name: Bronchoscope (flexible or rigid) and accessories Regulation Number: 874.4680 Product Code: BWH Classification: Class II
4. Device Description:
The Radial Jaw 14 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) are sterile, single-use devices. The Radial Jaw'14 4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length.
To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows
1
the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using the RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.
5. Indications for Use:
These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic evaluation. These forceps should not be used for any purpose other than their intended function.
6. Technological Characteristics:
The proposed Radial Jaw™ 4 Pulmonary Biopsy Forceps has a modified handle design as compared to the currently cleared Radial Jaw 4 Pulmonary Biopsy Forceps (K102336).
7. Performance Data:
Bench Testing has been performed on the proposed Radial Jaw™ 4 Pulmonary Biopsy Forceps to demonstrate that the modified handle design met the required specifications for the completed tests.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Radial Jaw"M 4 Pulmonary Bionsy Forceps are substantially equivalent to the currently cleared Radial Jaw™ 4 Pulmonary Biopsy Forceps (K102336).
000015
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the caduceus. The caduceus is depicted with three abstract, curved lines that resemble human figures or stylized wings, and the text is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation % Ms. Corrie Gooding 100 Boston Scientific Way Marlborough, MA 01752
MAY 1 6 2012
Re: K121186
Trade/Device Name: Radial Jaw™ 4 Pulmonary Biopsy Forceps Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: BWH Dated: April 17, 2012 Received: April 18, 2012
Dear Ms. Gooding:
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 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.
3
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,
E. U. Umph
Melvin R. Feldmann, MD
Malvina B. Eydelman, M/D. Director Division of Ophthalmic, Neurological, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K12 1186
SECTION 5 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications for Use:
Radial Jaw 4 Pulmonary Biopsy Forceps
To Be Determined
The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue endoscopically for histologic examination. These instruments should not be used for any purpose other than their intended use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 Ophthalmic, Neurological and Ear, Nose and Throat Devices
12/1186
Prescription Use (Per 21 CFR 801.109) ×