(80 days)
No
The device description focuses on mechanical components and operation, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are also focused on mechanical and reprocessing aspects.
No
The device is intended to remove tissue for diagnostic purposes (microscopic examination), not to treat or alleviate a disease or condition.
No
The device is intended to remove tissue for microscopic examination, which is a step in the diagnostic process but the device itself does not perform the diagnosis. It is a biopsy tool.
No
The device description explicitly details physical components made of stainless steel and other materials, and the performance studies focus on functional, sterilization, reprocessing, and tensile testing, all indicative of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. They are used to diagnose, monitor, or screen for diseases or conditions.
- Device Function: The description clearly states the device is a biopsy forceps intended to remove tissue specimens from the lungs or bronchial passageways from the patient's body.
- Purpose of the Tissue: The tissue is removed for microscopic examination, which is a separate process performed after the tissue is obtained by this device. The device itself is not performing the diagnostic test on the tissue.
This device is a surgical instrument used to obtain a sample for a diagnostic test (microscopic examination), but it is not the diagnostic test itself.
N/A
Intended Use / Indications for Use
Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.
Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs.
Product codes
BWH
Device Description
Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles. The physical characteristics of this device as well as 510(k) predicate devices are described below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs or bronchial passageways
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)
The following tests were performed on the Ballard Reusable Bronchial Biopsy Forceps.
-
- Functional
-
- Sterilization
-
- Reprocessing
-
- Tensile
Based on the indications for use, technological characteristics, and performance testing, the Ballard Reusable Bronchial Biopsy Forceps is safe and effective for its intended use.
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
§ 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
022398
Image /page/0/Picture/1 description: The image shows the logo for Ballard Medical Products. The word "BALLARD" is written in large, bold, black letters. A thick black line is drawn underneath the word. Below the line, the words "MEDICAL PRODUCTS" are written in smaller, black letters.
Appendix F Attachment 3.0
OCT 11 2002
July 19, 2002
510(k) Premarket Notification Summary per 807.92(a)
| Submitter Information: | Cindy Ellis
Ballard Medical Products
12050 Lone Peak Parkway
Draper, UT 84020
Tel. 801-572-6800
Fax 801-572-6869 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Biopsy Forceps, Non-Electric, Reusable,
Non-Ridged for use with bronchoscopes |
| Trade Name: | NA |
| Classification Name: | Forceps, Biopsy, Bronchoscope (Non-Rigid)
Ear Nose and Throat
21 CFR 874.4680
77BWH |
| Predicate Device: | Olympus FB Series Biopsy Forcep
510(k) K962555 |
Device Description:
Image /page/0/Figure/8 description: This image shows a diagram of a medical instrument. The diagram labels the different parts of the instrument, including the jaws, sheath length, control cable, and distal sheath diameter. The jaws are shown open, and the diameter is measured in the closed position. The diagram also shows the length of the sheath and the location of the control cable.
Figure A-1: Bronchial Forceps w/ exploded, breakaway detail of distal end
Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The
l
1
linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles. The physical characteristics of this device as well as 510(k) predicate devices are described below.
Intended to remove, by cutting, a specimen of tissue for microscopic Intended Use: examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.
Technological Characteristics (equivalence to predicate device) per 807.92(a)(6): The general design characteristics and function of the Ballard device is similar to the Olympus device.
| Characteristic | Subject Device
This submission | Predicate Device
(Olympus) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Typical label/advertising descriptors | | |
| Sheath length | 120cm | 105cm |
| Sheath diameter | 1.6mm | 1.6mm |
| Jaw diameter | 1.8mm | 1.8mm |
| Jaw geometry | Ellipsoid, fenestrated, no spike | Ellipsoid, fenestrated, no
spike plus various others |
| Recommended Reprocessing | | |
| Soak | Immediately after use | Immediately after use
5min to 3 hrs. |
| Enzymatic wash | Thoroughly clean with soft
brush to remove particulate.
Dry with sponge or gauze | N/A |
| Ultrasonic cleaning | 40KHz, 10 minutes | 30 minutes |
| Rinse | Clean running tap water | Clean running tap water |
| Autoclave | Pre-vacuum cycle
134°C
4min. exposure time
.2Mpa pressure
Gravity cycle
134°C
15 minute exposure time
.310Mpa pressure | Pre-vacuum
132°C-134°C
5min. exposure time |
Determination of Substantial Equivalence (non-clinical data) per 807.92(b)(1):
The following tests were performed on the Ballard Reusable Bronchial Biopsy Forceps.
-
- Functional
-
- Sterilization
-
- Reprocessing
-
- Tensile
Conclusions from non-clinical data per 807.92(b)(3):
Based on the indications for use, technological characteristics, and performance testing, the Ballard Reusable Bronchial Biopsy Forceps is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ballard Medical Products c/o Cindy Ellis Regulatory Affairs Specialist 12050 Lone Peak Parkway Draper, UT 84020
Re: K022398
Trade/Device Name: Reusable Bronchial Biopsy Forceps Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories. Regulatory Class: Class II Product Code: BWH Dated: July 19, 2002 Received: July 23, 2002
Dear Ms. Ellis:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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
Page 2 - Cindy Ellis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
4
APPENDIX A ATTACHMENT 2.0
. . . .
Reusable Bronchial Biopsy Forceps
INTENDED USE STATEMENT
Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PRESCRIPTION USE _ OR OVER-THE-COUNTER USE _
BALLARD
1EDICAL PRODUCTS