(88 days)
Not Found
No
The summary describes a mechanical aspiration catheter and its physical characteristics and performance testing. There is no mention of AI or ML capabilities, image processing, or data analysis that would suggest the use of such technologies.
No
Explanation: The device is used for the collection of duodenal or jejunal fluids for diagnostic analysis, which is a diagnostic purpose, not a therapeutic one.
No
The device is used for the collection of fluids for diagnostic analysis, not for performing the diagnostic analysis itself.
No
The device description clearly describes a physical catheter with a sheath-within-a-sheath design, a handle, and an elastomeric membrane. The performance studies also focus on physical characteristics like joint integrity, deployment force, and shelf life, which are typical for hardware medical devices. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used in vitro (outside the body) to examine specimens from the human body. They are used to provide information for diagnosis, monitoring, or screening.
- This device is used in vivo (inside the body) to collect a sample. The collected sample is then sent for diagnostic analysis, which would likely be performed using an IVD device.
- The intended use explicitly states it's for the collection of fluids for diagnostic analysis. It does not perform the diagnostic analysis itself.
Therefore, the Hobbs Medical Aspiration Catheter is a device used to facilitate the collection of a sample that will later be used with an IVD device. It is not an IVD device itself.
N/A
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.
Product codes
OCX
Device Description
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 Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
duodenal or jejunal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Applicable
§ 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.
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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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
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)(5)
21 CFR 807.92(a)(6)
5
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.