The Hobbs Medical Aspiration Catheter is a sheath within a sheath design. The inner sheath is actuated using a proximal handle. The inner sheath is protected by an elastomeric membrane that has a slit at the distal end to allow for the inner sheath to advance. The inner sheath has three side holes at the distal tip for collection of aspirate. Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an Aspiration Catheter, which is a medical device for collecting duodenal or jejunal fluids. However, the document does not contain information about a study involving an AI/Machine Learning component, nor does it provide the detailed specifics required to answer your questions about acceptance criteria, study design, ground truth, or expert involvement in the context of an AI-based device.

The document primarily focuses on demonstrating the substantial equivalence of the new Aspiration Catheter to a legally marketed predicate device (Hobbs Medical/Jayco Aspiration Catheter K844550) through physical performance testing, rather than a clinical study evaluating an AI algorithm's performance.

Therefore, I cannot provide the requested information based on the provided text, as it does not pertain to the development or validation of an AI/ML medical device.

Here's a breakdown of why I cannot answer each question based on the provided text:

A table of acceptance criteria and the reported device performance: The document mentions "Joint integrity testing," "Deployment force testing," "Endoscope compatibility testing," "Design verification and validation," "Protection of sample from contamination," and "Shelf life testing." However, specific numerical acceptance criteria (e.g., "deployment force must be less than X N") and the quantitative results for these tests are not provided. These are engineering/device performance tests, not AI performance metrics.
Sample sized used for the test set and the data provenance: No information on sample sizes for clinical or AI-specific testing is available. The provenance of any data (country of origin, retrospective/prospective) is also not mentioned, as it's not a data-driven AI study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert annotation or ground truth establishment for an AI algorithm.
Adjudication method: Not applicable. There's no AI algorithm requiring adjudication.
MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted human reader study.
Standalone (algorithm only without human-in-the loop performance) study: Not applicable. This device is not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" for this device would relate to its physical performance meeting specifications, not clinical diagnoses or classifications.
The sample size for the training set: Not applicable. No AI training was conducted.
How the ground truth for the training set was established: Not applicable. No AI training was conducted.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 24, 2024

Hobbs Medical, Inc. John Kirwan President 8 Spring St Stafford Springs, Connecticut 06076

Re: K241874

Trade/Device Name: Aspiration Catheter (2189) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: June 28, 2024 Received: June 28, 2024

Dear John Kirwan:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sivakami Venkatachalam -S

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241874

Device Name

Aspiration Catheter (2189)

Indications for Use (Describe)

To be utilized by a trained physician through a flexible endoscope for the collection of duodenal or jejunal fluids for diagnostic analysis.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

K241874 Page 1 of 2

Contact Details

21 CFR 807.92(a)(1)

Prepared on: 2024-09-24

Applicant Name	Hobbs Medical Inc.
Applicant Address	8 Spring St Stafford Springs CT 06076 United States
Applicant Contact Telephone	860-684-5875
Applicant Contact	Mr. John Kirwan
Applicant Contact Email	jkirwan@hobbsmedical.com

21 CFR 807.92(a)(2)

Device Trade Name	Aspiration Catheter (2189)
Common Name	Aspiration Catheter
Classification Name	Endoscope And Accessories
Regulation Number	876.1500
Product Code(s)	OCX

21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K844550	Hobbs Medical/Jayco Aspiration Catheter	OCX

21 CFR 807.92(a)(4)
Device Description Summary
The Hobbs Medical Aspiration Catheter is a sheath within a sheath design. The inner sheath is actuated using a proximal handle. The inner sheath is protected by an elastomeric membrane that has a slit at the distal end to allow for the inner sheath to advance. The inner sheath has three side holes at the distal tip for collection of aspirate. Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.
21 CFR 807.92(a)(5)
Intended Use/Indications for Use#### Intended Use/Indications for Use

To be utilized by a trained physician through a flexible endoscope for the collection of duodenal or jejunal fluids for diagnostic analysis.

Indications for Use Comparison

The intended use and indications for use of the subject device are the same as the predicate device.

Technological Comparison

The subject device and predicate device have the same intended use and are made from similar materials and technological features. The difference between the subject device and the predicate device has an inner and outer sheath. The inner sheath is for collection of the sample which is retracted into the inner sheath during placement and after aspiration during device removal to prevent sample contamination. This difference does not raise new questions of safety and effectiveness. The subject device is substantially equivalent to the predicate device.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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To demonstrate that the Hobbs Aspiration Catheter has acceptable performance for its intended use and is substantially equivalent to the predicate device the following testing was performed:

· Joint integrity testing
· Deployment force testing

· Endoscope compatibility testing

· Design verification and validation to confirm the device performs as intended

· Protection of sample from contamination
• Shelf life testing performed in accordance with ASTM 4169, ASTM F2096, ASTM F2096, ASTM F88

The subject device testing demonstrates that the device is adequately robust, has acceptable performance characteristics for its intended purpose compared to the predicate device, and provides protection against sample contamination. This testing provides reasonable assurance that the subject device is safe and effective, and is substantially equivalent to the predicate device.

Not Applicable

In conclusion, all performance testing conducted device performance and substantial equivalence to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.