The PneumRx Family of Biopsy Needles and Kits is intended for use in obtaining bone, vertebral body, and bone marrow biopsy specimens, and single and multiple tissue biopsy specimens of tissues or lesions, partial or complete removal of imaged abnormalities, in soft tissues, for applying radionuciide sources into the body, and for aspirating, or injecting various fluids or contents (e.g., sclerosing agents, vasoconstrictors, anesthetics, ethanol, saline, heparin, and other historically used, and/or generally accepted medical fluids in accordance with the judgment and training of the medical practitioner).

The PneumRx Family of Biopsy Needles and Kits is indicated for use in obtaining bone, vertebral body, and/or bone marrow biopsy using coring, cutting or aspiration, as well as providing and maintaining surgical site access with coaxial biopsy needle kits.

They are also indicated for use in percutaneous, open surgical, fine needle, tissue core, coaxial, and aspiration biopsy/ tissue sampling of soft tissues for:

. Microscopic, histologic, diagnostic, evaluation
Fluoroscopic, ultrasound (US), computed tomography (CT)/x-ray, mammographic imaging, . MRI (magnetic resonance imaging), and/or direct visualization
. Guiding biopsy needles to the target lesion
Avoiding punctures in non-penetrable anatomic obstacles (e.g., bone, spine) or vital structures (e.g., blood vessels, nerves)
Obtaining multiple biopsy, core biopsy, and aspiration biopsy tissue samples with partial or . complete removal of the imaged abnormality
Aspirating, draining, or injecting various fluids or contents in soft tissues, including . introduction of sclerosing agents or vasoconstrictors to control actual or potential bleeding
Pericardiocentesis, transhepatic cholorangiography, and other applications requiring injection . or aspiration of fluids
Lumbar puncture, spinal fluid sampling, local anesthetic injection to provide regional nerve . block/anesthesia, and amniocentesis
Manual application of a radionuclide source into or on the body for radiation therapy .
Including, but not limited to, the following anatomical locations and lesions; .
- Pleural cavity
- Lung
- Lymph nodes
- Thyroid
- Adrenals
- Soft tissue organs of the abdomen and thorax
- Abdominal cavity/ abdominal soft tissue masses
- Kidney
- Liver
- Spleen
- Pancreas
- Prostate
- Tumors
- Cysts
- Fluid spaces
- Soft tissue lesions or tissue spaces
- Breast:
  - The PneumRx Family of Biopsy Needles and Kits is indicated to provide breast . tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality;
  - The extent of a histologic abnormality cannot be reliably determined from its . mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Description

The PneumRx Family of Biopsy Needles and Kits are comprised of the following main components:

Standard and steerable biopsy needles in a range of sizes;
Standard straight and steering stylets compatible with a range of steerable and . standard biopsy needles;
. Remote Control Steering Handle accessory:
Procedure accessories including drapes, gauze sponges, syringes, scalpels, depth . markers, and prep tray.

AI/ML Overview

The provided text is a 510(k) summary for the PneumRx Family of Biopsy Needles and Kits. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, or AI-specific performance metrics.

However, based on the context of a 510(k) summary for a biopsy needle, we can infer the nature of the acceptance criteria and the type of study that would have been performed, even if the specifics are not explicitly stated in this document.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred): For a biopsy needle, acceptance criteria would typically revolve around:
- Biopsy Yield/Quality: Ability to obtain adequate tissue samples for histological examination.
- Mechanical Integrity/Functionality: Needle sharpness, rigidity, ease of penetration, absence of breakage, smooth operation of steering mechanisms (if applicable).
- Biocompatibility: Absence of adverse reactions to materials.
- Sterility: Maintenance of sterility.
- Safety: Absence of sharp edges, proper disposal, minimal tissue trauma during deployment and retraction.
Reported Device Performance: The document states:

"In addition, comparative performance test data demonstrated adequate device performance."
and
"The review of the indications for use and technical characteristics provided demonstrates that the PneumRx Family of Biopsy Needles and Kits is substantially equivalent to the predicate devices."
- Explanation: This is a high-level statement indicating that the device met the necessary performance characteristics to be deemed substantially equivalent to existing, legally marketed predicate devices. It does not provide specific metrics or raw data. For a biopsy device, "adequate performance" likely refers to successful tissue acquisition and mechanical function on in-vitro or in-vivo (animal) models, confirming it performs comparably to the predicates.

Acceptance Criteria (Inferred for a Biopsy Needle)	Reported Device Performance (Summary from Document)
Biopsy Yield and Quality	Demonstrated "adequate device performance" via comparative performance test data. This implies successful tissue acquisition for histological examination, comparable to predicate devices.
Mechanical Functionality (e.g., penetration, steering)	Demonstrated "adequate device performance" via comparative performance test data. This indicates the device's mechanical aspects (e.g., sharpness, rigidity, steerability) functioned as designed and comparably to predicate devices.
Material Biocompatibility	Implied to meet standards to achieve substantial equivalence.
Sterility	Implied to meet standards to achieve substantial equivalence.
Safety (e.g., absence of breakage, tissue trauma)	Implied to meet standards to achieve substantial equivalence.
Ease of Use	Covered under "functional features" that are similar to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size for a test set, nor the data provenance (e.g., country of origin, retrospective/prospective).
For a 510(k) of this nature (biopsy needle), performance testing often involves bench testing (mechanical strength, sharpness, fluid flow), and potentially animal studies for tissue yield, rather than large human clinical trials, unless a novel feature or indication warrants it.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. The 510(k) summary focuses on demonstrating substantial equivalence through technical characteristics and "comparative performance test data," which would primarily involve engineering and possibly animal model assessments. There is no indication of human expert review for establishing ground truth in a "test set" in the context of AI or diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. This concept is typically relevant for studies involving human interpretation or AI performance assessment, which is not the focus of this 510(k) summary.

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

No. This is a conventional medical device (biopsy needle), not an AI diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study was not performed or mentioned.

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

No. As explained above, this is a physical medical device, not an algorithm, so standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a biopsy needle, the "ground truth" during performance testing would likely be:
- Pathology: Confirmation of tissue type and quality from samples retrieved in animal models or bench test substitutes (e.g., gelatin, synthetic tissue).
- Mechanical Measurement: Engineering specifications for strength, sharpness, bend resistance, etc.
The document does not explicitly state the ground truth methodology but implies technical verification and potentially histological analysis of acquired tissue in performance testing.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, this is a physical medical device.

In summary:

The provided 510(k) summary for the PneumRx Family of Biopsy Needles and Kits serves to demonstrate substantial equivalence to predicate devices. It relies on the inherent safety and effectiveness of similar devices already on the market and "comparative performance test data" to show that the new device performs adequately. It does not contain the detailed clinical study data, acceptance criteria, or AI-specific performance metrics that would be found in a submission for a novel diagnostic device or an AI-powered system.

Summary

{0}------------------------------------------------

NOV - 3 2005

510(k) Summary for the PneumRx Family of Biopsy Needles and Kits Attachment 32:

I. General Information

Submitter:	PneumRx, Inc.530 Logue AvenueMountain View, CA 94043
Contact Person:	Anne C. WordenVP, Regulatory & Clinical Affairs
Summary Preparation Date:	October 24, 2005

II. Names

Device Names:	PneumRx Family of Biopsy Needles and Kits
---------------	-------------------------------------------

Primary Classification Names: Biopsy Needle and Needle Set

III. Predicate Devices

Cook® Sidearm Core Tissue Biopsy Device/Set (K041544) .
Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles (K021847) .
Boston Scientific Corp. Interject Injection Therapy Needle (K012864) .
. ISPG, Inc. Chiba Needle (K012358)
. INRAD, Inc. AccuCore Core Biopsy Needle (K981166)
INRAD, Inc. AccuCore Single Action Core Biopsy Device (K000612) .
INRAD, Inc. Co-axial Introducer Needle (K981721) .
Ethicon Endo-Surgery, Inc. Mammotome Biopsy System (K992813) .
Medical Device Technologies, Inc. Tru-Core™ I Reusable Biopsy Instrument . (K990839)
Medical Tech. Introducer Needle for Biopsy Needles (K981889) .
United States Endoscopy Group, Inc. Coaxial Needle (K971842) .
Parallax Medical Clearview Plus Bone and Vertebral Body Biopsy Needles . (K022169)
Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone and . Vertebral Body Biopsy Kit (K032943)
MD Technologies InterV Brand SnareLok Bone Marrow Biopsy Needle (K043523) .
. Orthovita, Inc. Imbibe Bone Marrow Aspiration Needle (K050795)
Medical Device Technologies, Inc. Chiba, Spinal, Automatic Cutting, General . Purpose Introducer, Techna-Cut Biopsy, Super-Core Biopsy, Breast Localization and Simon Breast Localization Needles (K980211)
. MD Manan™ Soft Tissue Biopsy Needles (K980122)
. Daum Corp. Aspiration-Biopsy Needle (K974575)
Promex/ US Biopsy Prostate Seeding Needle (K973184) ●
. Klein-Baker Med. Neo-Care Lumbar Puncture Kit (K970997)

{1}------------------------------------------------

. Allegiance Healthcare Clear Hub Spinal Needle (K982269)
SIMS Spinal Anesthesia Needle (K983858) ●
Ferguson Medical SmartGuide (K963894) .
� US Biopsy Automated Core Biopsy Device (K994272 and K011270)
. INRAD, Inc. Aspiration Biopsy Needle (K number unknown)
. Cook Chiba Aspiration Biopsy Needles (K851957)
. MD Manan™ Co-Axial Introducer Needles (K980004)
. Manan™M MD Super-Core Biopsy Needle (K974814)
MD Manan™ Techna-Cut Biopsy Needle (K974766) t

IV. Product Description

The PneumRx Family of Biopsy Needles and Kits are comprised of the following main components:

Standard and steerable biopsy needles in a range of sizes; ◆
Standard straight and steering stylets compatible with a range of steerable and . standard biopsy needles;
. Remote Control Steering Handle accessory:
Procedure accessories including drapes, gauze sponges, syringes, scalpels, depth . markers, and prep tray.

V. Indications for Use

The PneumRx Family of Biopsy Needles and Kits is intended for use in obtaining bone, vertebral body, and bone marrow biopsy specimens, and single and multiple tissue biopsy specimens of tissues or lesions, partial or complete removal of imaged abnormalities, in soft tissues, for applying radionuclide sources into the body, and for aspirating, draining, or injecting various fluids or contents (e.g., sclerosing agents, vasoconstrictors, anesthetics, ethanol, saline, heparin, and other historically used, approved, and/or generally accepted medical fluids in accordance with the judgment and training of the medical practitioner).

The PneumRx Family of Biopsy Needles and Kits is indicated for use in obtaining bone. vertebral body, and/or bone marrow biopsy using coring, cutting or aspiration, as well as providing and maintaining surgical site access with coaxial biopsy needle kits.

They are also indicated for use in percutaneous, open surgical. fine needle, tissue core, coaxial, and aspiration biopsy/ tissue sampling of soft tissues for:

. Microscopic, histologic, diagnostic, evaluation
Fluoroscopic, ultrasound (US), computed tomography (CT)/x-ray, mammographic . imaging, MRI (magnetic resonance imaging) and/or direct visualization
. Guiding biopsy needles to the target lesion
Avoiding punctures in non-penetrable anatomic obstacles (e.g., bone, spine) or vital . structures (e.g., blood vessels, nerves)
. Obtaining multiple biopsy, core biopsy, and aspiration biopsy tissue samples with partial or complete removal of the imaged abnormality

{2}------------------------------------------------

. Aspirating, draining, or injecting various fluids or contents in soft tissues, including introduction of sclerosing agents or vasoconstrictors to control actual or potential bleeding
Pericardiocentesis, transhepatic cholorangiography, and other applications requiring . injection or aspiration of fluids
Lumbar puncture, spinal fluid sampling, local anesthetic injection to provide regional . nerve block/anesthesia, and amniocentesis
. Manual application of a radionuclide source into or on the body for radiation therapy
Including, but not limited to, the following anatomical locations and lesions: .
- Pleural cavity ム
- ♪ Lung
- Lymph nodes
- Thyroid レ
- 必 Adrenals
- Soft tissue organs of the abdomen and thorax >
- Abdominal cavity/ abdominal soft tissue masses v
- Kidney や
- v Liver
- Spleen レ
- Pancreas >
- Prostate >
- Tumors >
- Cysts ア
- Fluid spaces P
- Soft tissue lesions or tissue spaces
- Breast:
  - The PneumRx Family of Biopsy Needles and Kits is indicated to provide . breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality;
  - The extent of a histologic abnormality cannot be reliably determined from its . mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

VI. Rationale for Substantial Equivalence

The PneumRx Family of Biopsy Needles and Kits shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent for use in obtaining single and multiple tissue biopsy specimens of tissues or lesions for microscopic, histologic, diagnostic, evaluation, for partial or complete removal of imaged abnormalities, in soft tissues, for applying radionuclide sources into the body, and for aspirating, draining, or injecting various fluids or contents to the predicate devices.

In addition, comparative performance test data demonstrated adequate device performance.

{3}------------------------------------------------

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the PneumRx Family of Biopsy Needles and Kits is substantially equivalent to the predicate devices.

VIII. Conclusion

The PneumRx Family of Biopsy Needles and Kits was found to be substantially equivalent to the predicate devices.

The PneumRx Family of Biopsy Needles and Kits shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.

NOV - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Anne C. Worden Vice President, Regulatory & Clinical Affairs PneumRx, Inc. 530 Logue Avenue Mountain View, California 94043

Re: K052435

Trade/Device Name: PneumRx Family of Biopsy Needles and Kits Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW, FCG, GAA, GDM, DWO Dated: September 2, 2005 Received: September 6, 2005

Dear Ms. Worden:

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.

{5}------------------------------------------------

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buehrig
for
Mel N. Miller

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K052435

PneumRx Family of Biopsy Needles and Kits Device Name:

Indications for Use:

They are also indicated for use in percutaneous, open surgical, fine needle, tissue core, coaxial, and aspiration biopsy/ tissue sampling of soft tissues for:

. Microscopic, histologic, diagnostic, evaluation
Fluoroscopic, ultrasound (US), computed tomography (CT)/x-ray, mammographic imaging, . MRI (magnetic resonance imaging), and/or direct visualization
. Guiding biopsy needles to the target lesion
Avoiding punctures in non-penetrable anatomic obstacles (e.g., bone, spine) or vital � structures (e.g., blood vessels, nerves)
Obtaining multiple biopsy, core biopsy, and aspiration biopsy tissue samples with partial or . complete removal of the imaged abnormality
Aspirating, draining, or injecting various fluids or contents in soft tissues, including . introduction of sclerosing agents or vasoconstrictors to control actual or potential bleeding
Pericardiocentesis, transhepatic cholorangiography, and other applications requiring injection . or aspiration of fluids
Lumbar puncture, spinal fluid sampling, local anesthetic injection to provide regional nerve . block/anesthesia, and amniocentesis
Manual application of a radionuclide source into or on the body for radiation therapy .

Prescription UseImage: Checkmark	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vartare Buellin

al, Restorative, and Neurological Devices

Page 1 of 2

510(k) Number K052435

{7}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K052435

Device Name: PneumRx Family of Biopsy Needles and Kits

Indications for Use: - Continued from previous page -

Including, but not limited to, the following anatomical locations and lesions; .
- Pleural cavity v
- Lung
- Lymph nodes
- Thyroid
- Adrenals
- Soft tissue organs of the abdomen and thorax >
- Abdominal cavity/ abdominal soft tissue masses
- ♪ Kidney
- Liver
- Spleen
- ン Pancreas
- い Prostate
- Tumors
- Cysts
- Fluid spaces
- 5 Soft tissue lesions or tissue spaces
- ン Breast:
  - The PneumRx Family of Biopsy Needles and Kits is indicated to provide breast . tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality;
  - The extent of a histologic abnormality cannot be reliably determined from its . mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Prescription Use > (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buelind

Division of General. Restorative, and Neurological Devices

Page 2 of 2

510(k) Number K050435

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.