The modified Lung Biopsy Needle is a sterile, disposable device, used for submucosal aspiration biopsy of the bronchial tree through the accessory channel of a bronchoscope. It consists of a 22 gauge needle, 100 cm outer catheter and handle mechanism. The handle mechanism is used to extend and retract the needle with the proximal portion inclusive of the aspiration port.

AI/ML Overview

The provided document is a 510(k) premarket notification for a modification to a medical device, specifically a Wilson-Cook Lung Biopsy Needle. It is not a study assessing the performance of an AI/ML device, but rather a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, much of the requested information regarding AI device performance metrics, study design, and ground truth establishment is not applicable.

However, I can extract the information related to the device's acceptance criteria and how "performance" (in the context of a 510(k) for a non-AI device) was demonstrated.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device modification, "acceptance criteria" primarily relate to demonstrating that the modified device functions as intended and is as safe and effective as the predicate device. The performance is demonstrated through design verification, ensuring it meets predetermined criteria.

Characteristic	Acceptance Criteria (Predetermined)	Reported Device Performance
Intended Use	Submucosal aspiration biopsy of the bronchial tree (aligned with predicate).	Meets the intended use: "Used for submucosal aspiration biopsy of the bronchial tree." This is consistent with the predicate Wang/Mill-Rose Transbronchial Aspiration Needle.
Outer Catheter Material	Use of Polyetheretherketone (PEEK) with metal hub at distal tip (changed from Polytetrafluoroethylene).	The device incorporated PEEK with a metal hub at the distal tip. Compatibility and functionality of this material are implicitly accepted through design verification.
Needle Gauge	22 GA stainless steel needle.	The device uses a "22 GA stainless steel needle." This matches the predicate devices.
Maximum Needle Extension	13mm.	The device's maximum needle extension is 13mm. This matches the predicate devices.
Outer Catheter Length	100cm.	The device's outer catheter length is 100cm. This matches the original Wilson-Cook predicate.
Sterility	Sterile, Disposable; SAL of 10-6 in accordance with AAMI Standard 11135.	"Validated EO cycle in accordance with AAMI Standard 11135 using an Sterility: SAL of 10-6." Meets the criteria for sterility.
Biocompatibility	Reasonable assurance of biocompatibility for patient-contacting materials.	"Reasonable assurance of biocompatibility... established through an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results." This implies tests (though not detailed) met internal acceptance criteria for material safety.
Design Integrity & Functionality	All results obtained during Design Verification met predetermined acceptance criteria for the product line.	"During Design Verification, visual, dimensional and functional testing... was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." (Specific results or acceptance criteria are not detailed in this summary).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The "Design Verification" section mentions "visual, dimensional and functional testing" but does not provide specific sample sizes for these tests. This is typical for a 510(k) for a physical device where testing might involve a limited number of manufactured units to confirm specifications.
Data Provenance: Not applicable in the context of clinical data for an AI device. The data refers to internal engineering and quality testing performed by Wilson-Cook Medical Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is not an AI/ML device that requires expert-established ground truth for a test set. Design verification relies on engineering specifications and physical measurements.

4. Adjudication method for the test set

Not applicable as this is not an AI/ML device involving expert review adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is not an AI/ML device.

7. The type of ground truth used

For this device, "ground truth" would be the engineering specifications, design requirements, and established standards (e.g., AAMI Standard 11135 for sterility, ISO standards for biocompatibility if referenced internally). The design verification tests against these objective criteria.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable as this is not an AI/ML device.

Summary

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SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK LUNG BIOPSY RE: 1998 NEEDLE 8 DEC

510(k) Summary of Safety & Effectiveness

Submitted By: Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105

Device Description: The modified Lung Biopsy Needle is a sterile, disposable device, used for submucosal aspiration biopsy of the bronchial tree through the accessory channel of a bronchoscope. It consists of a 22 gauge needle, 100 cm outer catheter and handle mechanism. The handle mechanism is used to extend and retract the needle with the proximal portion inclusive of the aspiration port.

Trade Name:	Wilson-Cook Lung Biopsy Needle
Common/Usual Name:	Aspiration Needle
Classification Name/Code:	Bronchoscope Accessory 77 KTI EOQ
Classification:	FDA has classified similar devices as Class II as per 21 CFR § 874.4680. This device falls within the purview of the Ear, Nose and Throat Device Panel.
Establishment Registration Number:	1037905

Validated EO cycle in accordance with AAMI Standard 11135 using an Sterility: SAL of 106.

Performance Standards: No performance standards applicable to Bronchoscope Accessories have been established by the Food and Drug Administration.

Used for submucosal aspiration biopsy of the bronchial Intended Use: tree.

Predicate Devices:

Predicate Device	Manufacturer	Document ControlNumber
Wilson-Cook Lung BiopsyNeedle	Wilson-Cook Medical Inc.	K8977050A
Transbronchial AspirationNeedle	Wang/Mill-Rose	K914181

Substantial Equivalence:

The modified Lung Biopsy Needle is substantially equivalent to the referenced predicate devices in that it is similar with respect to technological characteristics and intended use.

Page. 10

Confidential 11/13/98

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SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK LUNG BIOPSY RE: NEEDLE

Characteristic	Predicate Wilson-Cook Lung BiopsyNeedle(K897050A)	Predicate Wang/Mill-Rose TransbronchialAspiration Needle(K914181)	ModifiedWilson-CookLung BiopsyNeedle[Subject of"Special"510(k)]
Intended Use	Biopsy of lung tissue.	Aspiration biopsy ofthe bronchial tree.	Submucosalaspirationbiopsy of thebronchial tree.
Outer Catheter	Polytetrafluoroethylenewith metal hub at distaltip.	Polytetrafluoroethylenewith metal hub at distaltip.	Polyetheretherketone (PEEK)with metal hubat distal tip.
Needle	22 GA stainless steelneedle affixed to aninner catheter	22 GA Needle	22 GA stainlesssteel needle.
Maximum NeedleExtension	13mm	13mm	13mm
Outer CatheterLength	100cm	140 cm	100cm
Sterility	Sterile, Disposable	Sterile, Disposable	Sterile,Disposable

510(k) Summary of Safety & Effectiveness (continued)

Biocompatibility:

Reasonable assurance of biocompatibility for the patient contacting materials has been established through an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results.

Design Control/Risk Analysis/Design Verification:

Design Control, risk analysis and design verification activities for the subject of this 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21CFR § 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, visual, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.

Page 11

Confidential 11/13/98

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.

Re:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10008 8 DEC

Wilson-Cook Medical, Inc. C/O Paula Joyce QA/RÅ Manager 4900 Bethania Station Rd. Winston-Salem, NC 27105 K984157 Wilson-Cook Lung Biopsy Needle Dated: November 13, 1998 Received: November 19, 1998 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO

Dear Ms. Joyce:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approvial), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitn 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsma/dsmamain.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Re: Special 510(k): Device odification for the Wilson-Cook Lung Biopsy Needle.

510(k) Number (if known): _ K984157

Device Name: Wilson-Cook Lung Biopsy Needle

Indications For Use:

Used for submucosal aspiration biopsy of the bronchial tree.

(PLE ASE 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, Abdominal, ENT,
and Radiological Devices
510(k) Number K984157

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Formal 1-2-96)

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.