(45 days)
The NDO Surgical, Inc. Overtube is indicated for endoscopic use when repeated endoscopic intubation is anticipated.
The NDO Surgical, Inc. Overtube is an extruded, flexible, polyvinyl chloride tube, reinforced with stainless steel wire braiding. The stainless steel reinforcing is fully encapsulated in the PVC tube. The proximal end of the Overtube has a polyurethane flange that is bonded to the tube.
The NDO Surgical, Inc. Overtube is inserted through the patient's mouth into the esophagus following standard medical procedures. Once in place, the NDO Surgical, Inc. Overtube is used as a channel for passage of an endoscope and/or endoscopic instruments into the esophagus. It is designed and intended for circumstances in which repeated endoscopic intubation may be necessary.
The provided document is a 510(k) premarket notification letter from the FDA regarding the NDO Surgical Overtube. This type of document is for a medical device that claims substantial equivalence to a legally marketed predicate device, rather than a novel AI/ML device requiring clinical studies with acceptance criteria, ground truth, and reader studies.
Therefore, the specific information requested about acceptance criteria, study details (sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not found within this document. This document focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and material composition.
Here's what can be extracted, although it does not directly answer the detailed questions about acceptance criteria and clinical study specifics:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or reported device performance in the context of clinical study outcomes or AI/ML performance metrics. The FDA's substantial equivalence determination for this device is based on its comparison to a predicate device, as opposed to meeting specific performance thresholds from a de novo clinical trial.
However, the document states: "The NDO Surgical, Inc. Overtube is substantially equivalent to the predicate of the Bard Endoscopic Overtube in intended use, technological characteristics of the material compostion and processes used in its application." This statement implies that the "acceptance criteria" for clearance was the demonstration of sufficient similarity to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a clinical study with a test set of data. The submission is based on comparison to a predicate device.
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. There is no mention of ground truth establishment by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of a test set or adjudication method.
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. This document pertains to a physical medical device (an overtube), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The concept of ground truth in the context of AI/ML or clinical study outcomes is not relevant here. Substantial equivalence is established through comparison to a predicate device.
8. The sample size for the training set:
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set or ground truth establishment in this context.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NDO Surgical, Inc. Mr. Jeff Cerier Director of Product Development 125 High Street, Suite 7 Mansfield, MA 02048
JUL 2 7 2015
Re: K002018
Trade/Device Name: NDO Surgical Overtube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated (Date on orig SE Itr): June 29, 2000 Received (Date on orig SE ltr): July 3, 2000
Dear Mr. Cerier,
This letter corrects our substantially equivalent letter of August 17, 2000.
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. 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
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (7) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1150.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Koo 2018 510(k) Number (if known):
NDO Surgical, Inc. Overtube Device Name:
Indications For Use:
The NDO Surgical, Inc. Overtube is indicated for endoscopic use when repeated endoscopic intubation is anticipated.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K002018
()(un) ] [
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AUG 1 7 2000
Image /page/3/Picture/1 description: This image shows the logo and contact information for NDO Surgical, Inc. The address is 125 High Street, Suite 7, Mansfield, MA 02048. The phone number is 508-337-8881, and the fax number is 508-337-8882. The text "510K Summary" is also present in the image.
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- Sponsor Name Sponsor/Manufacturer: NDO Surgical, Inc. 125 High Street, Suite #7 Mansfield, MA 02048 Telephone: 877-337-8887 Contact Individual: Jeff Cerier
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- Device Name NDO Surgical, Inc. Overtube
4. Device Description
The NDO Surgical, Inc. Overtube is an extruded, flexible, polyvinyl chloride tube, reinforced with stainless steel wire braiding. The stainless steel reinforcing is fully encapsulated in the PVC tube. The proximal end of the Overtube has a polyurethane flange that is bonded to the tube.
The NDO Surgical, Inc. Overtube is inserted through the patient's mouth into the esophagus following standard medical procedures. Once in place, the NDO Surgical, Inc. Overtube is used as a channel for passage of an endoscope and/or endoscopic instruments into the esophagus. It is designed and intended for circumstances in which repeated endoscopic intubation may be necessary.
ર. Intended Use
The NDO Surgical, Inc. Overtube is intended for use with an endoscope when repeated endoscopic intubation is anticipated.
Comparison of Technological Characteristics
The NDO Surgical, Inc. Overtube is substantially equivalent to the predicate of the Bard Endoscopic Overtube in intended use, technological characteristics of the material compostion and processes used in its application. These characteristics support the concept of substantial equivalence.
§ 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.