(94 days)
Not Found
No
The device description focuses on mechanical and physical properties (flexibility, rigidization via vacuum) and does not mention any computational or data-driven components indicative of AI/ML. The performance studies are also focused on mechanical and biocompatibility testing.
Yes
The device is used to facilitate treatment in the gastrointestinal tract, which implies a therapeutic purpose.
No
The device is described as an overtube used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the GI tract. Its function is mechanical (facilitating access, maintaining shape) rather than gathering information for diagnosis.
No
The device description explicitly details a physical, flexible overtube with a stopcock and vacuum connection, indicating it is a hardware device. The performance studies also focus on biocompatibility and mechanical testing of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pathfinder™ Endoscope Overtube is a medical device used during an endoscopic procedure within the gastrointestinal tract. Its function is to facilitate the procedure by aiding in intubation, endoscope changes, and treatment. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states its purpose is to be used with an endoscope for procedures in the GI tract. This is a procedural aid, not a diagnostic test performed on a sample.
Therefore, the Pathfinder™ Endoscope Overtube is a medical device used for procedural support, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pathfinder™ Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).
Product codes
FED
Device Description
The Pathfinder™ Endoscope Overtube (Pathfinder™) device consists of a flexible overtube that may be connected to vacuum for rigidization via an attached stopcock and is used with an endoscope for procedures in the gastrointestinal tract. The stopcock is connected to the vacuum line which is connected to free space within the device and is completely contained, forming the vacuumable volume. The stopcock has two positions: the first position connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible condition, and the second position connects the device to a source of vacuum to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.
There are no associated device accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal (GI) tract
Indicated Patient Age Range
adult patients (22 years of age and older)
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Pathfinder™ was conducted in accordance with the guidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process," June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA and other applicable standards. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Pyrogenicity
The Pathfinder™ is considered to contact breached or compromised surfaces for a duration of less than 24 hours.
Mechanical Testing
- Simulated use testing
- Lubricity
- Insufflation
- Insertion/Removal
- Steering
- Navigation
- Rigidization/De-Rigidization
- Endoscope Compatibility
The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the Pathfinder™ shall perform as intended in the specified use conditions. The data demonstrate that the Pathfinder™ performs comparably to the predicate device currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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August 30, 2019
Neptune Medical, Inc. % Ian Broome, M.S. Consultant AlvaMed. Inc. 935 Great Plain Avenue, #166 Needham, MA 02492
Re: K191415
Trade/Device Name: Pathfinder™ Endoscope Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FED Dated: August 15, 2019 Received: August 16, 2019
Dear Ian Broome:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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.
for
Martha Betz, Ph.D. Acting Assistant Division 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
510(k) Number (if known) K191415
Device Name Pathfinder™ Endoscope Overtube
Indications for Use (Describe)
The Pathfinder™ Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5.0 TRADITIONAL 510(K) SUMMARY FOR PATHFINDER™ ENDOSCOPE OVERTUBE DEVICE
I. SUBMITTER
Neptune Medical, Inc. 1828 El Camino Real, Suite 508 Burlingame, CA 94010
Phone: (617) 517-4932 Fax: (617) 249-0955
Contact Person: lan Broome, AlvaMed, Inc. Date Prepared: August 28, 2019
II. DEVICE
Name of Device: Pathfinder™ Endoscope Overtube (Model GI 085140) Common or Usual Name: Endoscopic Access Overtube Classification Name: Endoscope and accessories (21 CFR 876.1500) Requlatory Class: II Product Code: FED
III. PREDICATE DEVICE
KMS Medical EndoGuide (K063654)
IV. DEVICE DESCRIPTION
The Pathfinder™ Endoscope Overtube (Pathfinder™) device consists of a flexible overtube that may be connected to vacuum for rigidization via an attached stopcock and is used with an endoscope for procedures in the gastrointestinal tract. The stopcock is connected to the vacuum line which is connected to free space within the device and is completely contained, forming the vacuumable volume. The stopcock has two positions: the first position connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible condition, and the second position connects the device to a source of vacuum to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.
There are no associated device accessories.
V. INDICATIONS FOR USE
The Pathfinder™ Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).
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The Indications for Use statement for the Pathfinder™ Endoscope Overtube device above is similar to the predicate device; any differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for endoscopic treatment in the GI tract.
The table below provides an overview of the intended patient population, environment of use, and contraindications.
Intended Population, Environment of Use, and Contraindications
| Intended Population: | Adults (≥ 22 years old) requiring gastrointestinal endoscopic
treatment |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Environment of
Use: | Gastrointestinal tract |
| Contraindications: | Those who have had extensive abdominal surgeries may be poor
candidates because of adhesions or altered anatomy.
Use contraindicated in patients with esophageal bleeding, lesion(s),
and/or laceration; esophageal strictures and/or varices; laryngeal
perforation; trauma to teeth, gums, and/or pharynx; aspiration
pneumonia; or any other condition that may preclude endoscopy. |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| | Subject Device:
Pathfinder™ Endoscope Overtube | Predicate Device:
KMS EndoGuide |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Neptune Medical, Inc. | KMS Medical, LLC |
| 510(k) Number | (to be determined) | K063654 |
| Product Code | FED | FDF, subsequently FED |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Regulation
Description | Endoscope and accessories. | Endoscope and accessories. |
| Common
Name | Endoscopic Access Overtube,
Gastroenterology-urology | Colonoscope and Accessories,
Flexible/Rigid |
| Intended Use | The Pathfinder™ Endoscope Overtube
is intended to be used with an
endoscope to facilitate intubation,
change of endoscopes, and treatment
in the gastrointestinal (GI) tract in adult
patients (22 years of age and older). | The EndoGuide is intended to be used
with an endoscope to facilitate
intubation, change of endoscopes and
removal of multiple polyps and/or
foreign bodies. |
| Sterility | Ethylene Oxide (EO) Sterilization | Unknown, believed to be EO |
| Single-Use | Yes | Yes |
5
| | Subject Device:
Pathfinder™ Endoscope Overtube | Predicate Device:
KMS EndoGuide |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Design
Characteristics | Vacuum-assisted rigidizing overtube
for endoscopic procedures in the Gl
Tract
Internal wire-reinforced member
● | Vacuum-assisted rigidizing overtube
●
for endoscopic procedures in the GI
Tract
· Internal wire-reinforced member |
Both devices are intended as assistive aids to the medical practitioner for endoscopic treatment in the GI tract.
The subject and predicate devices are based on the following same technological elements:
- . an internal wire-reinforced member to the device;
- switchable vacuum-based rigidization/de-rigidization; and ●
- dimensions and design characteristics intended for use with pediatric endoscopes. ●
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Pathfinder™ was conducted in accordance with the guidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process," June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA and other applicable standards. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- . Pyrogenicity
The Pathfinder™ is considered to contact breached or compromised surfaces for a duration of less than 24 hours.
Mechanical Testinq
- . Simulated use testing
- Lubricity
- Insufflation ●
- Insertion/Removal ●
- Steering ●
- Navigation ●
- Rigidization/De-Rigidization ●
- Endoscope Compatibility
6
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the Pathfinder™ shall perform as intended in the specified use conditions. The data demonstrate that the Pathfinder™ performs comparably to the predicate device currently marketed for the same intended use.