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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ballard Reusable Bronchial Biopsy Forceps, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets for each test. Instead, it describes various tests performed and implies that the device met the necessary performance for substantial equivalence. The "reported device performance" is primarily qualitative, stating that the device passed the tests.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence	Similar general design characteristics and function to predicate device.
Sheath Length	120cm (similar to predicate's 105cm, deemed acceptable)
Sheath Diameter	1.6mm (matches predicate)
Jaw Diameter	1.8mm (matches predicate)
Jaw Geometry	Ellipsoid, fenestrated, no spike (similar to predicate)
Reprocessing Effectiveness	Successfully withstood recommended reprocessing cycles (Soak, Enzymatic wash, Ultrasonic cleaning, Rinse, Autoclave)
- Soak	Immediately after use (matches predicate)
- Enzymatic wash	Thoroughly clean, dry (no direct comparison, but implies effectiveness)
- Ultrasonic cleaning	40KHz, 10 minutes (predicate: 30 minutes, implies 10 min effectively cleans)
- Rinse	Clean running tap water (matches predicate)
- Autoclave	Pre-vacuum cycle: 134°C, 4min, .2Mpa pressure; Gravity cycle: 134°C, 15 min, .310Mpa pressure (different from predicate's 132-134°C, 5min, but implies effectiveness)
Sterilization Effectiveness	Passed sterilization tests (no specific details provided)
Tensile Strength	Passed tensile tests (no specific details provided)
Overall Safety & Effectiveness	"Safe and effective for its intended use" based on submitted data.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not provide details on the sample size for the test set used in the functional, sterilization, reprocessing, or tensile equivalence tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The studies conducted are primarily engineering/performance tests (functional, sterilization, reprocessing, tensile) directly comparing the device to a predicate, not clinical studies requiring expert ground truth for interpretation of observational data.

4. Adjudication Method (for the test set)

This information is not applicable as the tests performed are not clinical trials requiring adjudication of expert interpretations but rather performance tests against defined specifications or predicate device characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing against a predicate device.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was Done

This question is not applicable as the device is a physical medical instrument (biopsy forceps), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be:

Performance Specifications/Benchmarks: For functional tests, this would be the expected performance of a biopsy forceps.
Predicate Device Characteristics: For sheath length, diameter, jaw geometry, and reprocessing parameters, the Olympus FB Series Biopsy Forcep (K962555) served as the direct comparator for substantial equivalence.
Established Industry Standards/Protocols: For sterilization, reprocessing, and tensile strength, the tests would have been performed according to accepted methods to demonstrate safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not a learning algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as above.

Summary

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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 EllisBallard Medical Products12050 Lone Peak ParkwayDraper, UT 84020Tel. 801-572-6800Fax 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 Throat21 CFR 874.468077BWH
Predicate Device:	Olympus FB Series Biopsy Forcep510(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

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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 DeviceThis 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, nospike plus various others
Recommended Reprocessing
Soak	Immediately after use	Immediately after use5min to 3 hrs.
Enzymatic wash	Thoroughly clean with softbrush 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 cycle134°C4min. exposure time.2Mpa pressureGravity cycle134°C15 minute exposure time.310Mpa pressure	Pre-vacuum132°C-134°C5min. 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.

1. Functional
1. Sterilization
1. Reprocessing
1. 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.

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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.

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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

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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

Regulation Number and Section

§ 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.