(182 days)
The ShortShot Saeed Hemorrhoidal MultiBand Ligator with TriView Anoscope is used to ligate internal hemorrhoids facilitated by an anoscope, for use in adult patients only.
The ShortShot Saeed Hemorrhoidal Multi-Band Ligator consists of a polycarbonate barrel attached to the tip of a polycarbonate handle. The barrel is preloaded with four (4) latex rubber ligation bands, and a trigger cord is utilized for deployment of the bands. The TriView Anoscope consists of transparent polystyrene Anoscope and Obturator. The TriView Anoscope enables the physician to dilate the anal canal, to complete a visual examination of the anal-rectal anatomy, and isolate the internal hemorrhoids for ligation using the ShortShot Saeed Hemorrhoidal Multi-Band Ligator.
The provided 510(k) summary for the "ShortShot Saeed Hemorrhoidal Multi-Band Ligator with TriView Anoscope" does not contain information about explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device, rather than providing independent performance metrics against predefined acceptance criteria.
Therefore, many of the requested fields cannot be filled as the information is not present in the document.
Here's a breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Substantially equivalent to predicate devices (Wilson-Cook Multiple Band Ligator and O'Regan Disposable Anoscope) in terms of Intended Use, Indications for Use, performance characteristics tested, and sterility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The summary makes no mention of a specific test set or clinical study with a defined sample size for the new device's performance. The "performance data" mentioned refers to the comparison with predicate devices, not a new study.
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 / Not provided. No test set or ground truth establishment by experts is described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set or adjudication process is described.
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:
- No. This device is a mechanical ligator and anoscope, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a mechanical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. As no new performance study is described, there's no ground truth established for the new device. The device's "effectiveness" is inferred by its substantial equivalence to already cleared devices.
8. The sample size for the training set:
- Not applicable / Not provided. This is not a machine learning or AI device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable / Not provided. See above.
Summary of the Study (or lack thereof):
The submission for the "ShortShot Saeed Hemorrhoidal Multi-Band Ligator with TriView Anoscope" relies on a substantial equivalence comparison to two predicate devices:
- Ligator component: Deemed "identical" to the currently marketed predicate device (Wilson-Cook Multiple Band Ligator, K020526).
- Anoscope component: Deemed "substantially equivalent" to the currently marketed predicate device (O'Regan Disposable Anoscope, K020702).
The "study" in this context is the comparison of the proposed device's characteristics (Intended Use, Indications for Use, performance characteristics, and sterility) against those of the predicate devices. The document states that based on this comparison, the manufacturer believes the proposed device is substantially equivalent. This type of submission generally does not require new clinical performance data if substantial equivalence can be demonstrated through design, materials, and intended use comparison.
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K060623
510k Summary
| Name: | Cook Ireland | |
|---|---|---|
| Address: | O' Holloran RoadNational Technology ParkLimerickIreland | SEP - 6 2006 |
| Phone:Fax: | 353 61 334440353 61 334441 | |
| Contact Person: | Emmett Devereux, Quality & RegulatoryManagerSinead Burke, Regulatory Affairs Specialist | |
| Date: | August 10, 2006 | |
| Trade Name: | ShortShot Saeed Hemorrhoidal Multi-BandLigator with TriView Anoscope | |
| Common Name: | Hemorrhoidal Multiple Band LigatorAnoscope | |
| Classification Name: | Ligator, Hemorrhoidal, GU, 78FHNAnoscope, Non Powered, GU, FER | |
| Legally Marketed Devices: | Wilson-Cook Multiple Band Ligator (K020526)O'Regan Disposable Anoscope (K020702) | |
| Description of the Device: | The ShortShot Saeed Hemorrhoidal Multi-Band Ligator consists of a polycarbonatebarrel attached to the tip of a polycarbonatehandle. The barrel is preloaded with four (4) |
The TriView Anoscope consists of transparent polystyrene Anoscope and Obturator. The TriView Anoscope enables the physician to dilate the anal canal, to complete a visual examination of the anal-rectal anatomy, and isolate the internal hemorrhoids for ligation using the ShortShot Saeed Hemorrhoidal Multi-Band Ligator.
latex rubber ligation bands, and a trigger cord
is utilized for deployment of the bands.
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Intended use: The ShortShot Saeed Hemorrhoidal MultiBand Ligator with TriView Anoscope is used to ligate internal hemorrhoids facilitated by an anoscope, for use in adult patients only. Comparison of We believe the proposed Anoscope Characteristics: component of the device to be substantially equivalent to the currently marketed predicate device as cleared by K020702. We believe the proposed Ligator component
Performance Data:
We believe the proposed device to be substantially equivalent to the named predicate devices in terms Intended Use, Indications for Use, performance characteristics tested and sterility.
of the device to be identical to the currently marketed predicate device as cleared by
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Sinead Burke Regulatory Affairs Specialist Cook Ireland Ltd. O'Halloran Road National Technology Park Limerick IRELAND
SEP - 6 2006
Re: K060623
Trade/Device Name: ShortShot Saeed Hemorrhoidal Multi-Band Ligator with TriView Anoscope Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Product Codes: FHN Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: FER Regulatory Class: II Dated: August 10, 2006 Received: August 14, 2006
Dear Ms. Burke:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one re reviewe and have determined the device is substantially equivalent (for the indications for reservlated in the enclosure) to legally marketed predicate devices marketed in interstate commerce abo battle 11 28, 1976, the enactment date of the Medical Device Amendments, or to devices that prov to way 20, 1970, and cardance 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 therefore, mations 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 (Premarket r your are roo be subject to such additional controls. Existing major regulations affecting your Approval), It 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.
Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is written in a cursive font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary. The text emphasizes the organization's mission to safeguard and improve public health.
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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours.
Nancy C Hodgon
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
K060623 510(k) Number (if known):
Device Name: ShortShot Saeed Hemorrhoidal Multi-Band Ligator with TriView Anoscope
Indications for Use:
The ShortShot Saeed Hemorrhoidal MultiBand Ligator with TriView Anoscope is used to ligate internal hemorrhoids facilitated by an anoscope, for use in adult patients only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_ of _1
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number__
§ 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.