(71 days)
The disposable Overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval and/or for endoscopic re-intubations.
Not Found
This is an FDA 510(k) clearance letter for the "Disposable Overtube" (K040836). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria as would be found in a PMA (Pre-Market Approval) application or a more recent 510(k) submission that includes performance studies.
Therefore, the provided text does not contain the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. The letter confirms the device's substantial equivalence to a legally marketed predicate device based on its intended use for foreign body or tissue retrieval and/or for endoscopic intubations in conjunction with a flexible endoscope.
To address the prompt fully, if this were a typical AI/ML medical device submission, the requested information would be found in detailed performance studies within the 510(k) summary or a separate clinical study report. Since that information is absent in the provided document, I cannot populate the table or answer the specific questions.
However, I can extract the following limited information from the provided document:
- Device Name: Disposable Overtube
- Regulation Number: 21 CFR §876.1500
- Regulation Name: Endoscope and accessories
- Regulatory Class: II
- Product Code: 78 KOG
- Indications for Use: The disposable Overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval and/or for endoscopic intubations.
Without a detailed clinical or performance study report included in the 510(k) summary, which is not part of this clearance letter, I cannot provide the specific information requested about acceptance criteria, study design, or ground truth.
If this were a document that contained such information, the output would be structured as follows (but is currently unfillable from the provided text):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| [Not provided in document] | [Not provided in document] |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: [Not provided in document]
- Data Provenance: [Not provided in document] (e.g., country of origin, retrospective/prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: [Not provided in document]
- Qualifications of Experts: [Not provided in document]
4. Adjudication method for the test set
- Adjudication Method: [Not provided in document]
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study Done? [Not provided in document]
- Effect Size (human readers with AI vs. without AI): [Not applicable/Not provided in document for a non-AI device]
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study Done? [Not applicable for this device as it's not an AI/ML algorithm]
7. The type of ground truth used
- Ground Truth Type: [Not provided in document; typically clinical outcomes, pathology, expert consensus for imaging devices]
8. The sample size for the training set
- Training Set Sample Size: [Not applicable for this type of device submission, as it's not an AI/ML algorithm relying on a training set]
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): [Not applicable for this type of device submission]
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Ms. Gretchen Y. Cohen Executive Vice President US Endoscopy 5976 Heisley Road MENTOR OH 44060
Re: K040836
Trade/Device Name: Disposable Overtube Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 KOG Dated: May 24, 2004 Received: May 25, 2004
Dear Ms. Cohen:
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 for use bated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner or proc to rial 20, 20, 2017 11:11 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 r ou may, aterere, misions 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 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 I Tease be actived that I Drimination that your device complies with other requirements of the Act that I Driviso mas and regulations administered by other Federal agencies. You must or uny Federal barates in requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), accemis (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.
{1}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocgin marketing your antial equivalence of your device to a legally premarket nothication. The PDA inding of backlania equivalians 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 If you desire specific advice for your device on our lief to good number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, Tor questions on the promotion and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, possessed on Main - Other agences Othice of Compliance at (501) 574-1057. Fast, production of Soltan. Other general by reference to premarked nonitation (21 Or Fer and on 17) in the Division of Small information on your responsionalites and consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-democr Manufacturers, International and Collisation Fibroads.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040836
Device Name: Disposable Overtube
Indications for Use:
The disposable Overtube is a device used in conjunction with a The disposable Overtube is a device dood in terrjans.
flexible endoscope for foreign body or tissue retrieval and/or for endoscopic nextble endoscope for relige endoscope intubations.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David M. Chapman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of __
§ 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.