(182 days)
Not Found
No
The device description and intended use describe a mechanical ligator and anoscope, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
Yes
The device is used to ligate internal hemorrhoids, which is a therapeutic procedure aimed at treating a medical condition.
No
Explanation: The device is described as a ligator and anoscope used for a therapeutic procedure (ligation of hemorrhoids) and visual examination, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components made of polycarbonate and polystyrene, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ShortShot Saeed Hemorrhoidal Multi-Band Ligator with TriView Anoscope is a surgical instrument used directly on the patient's body to treat internal hemorrhoids. It is used for ligation (tying off) of tissue, not for analyzing samples.
The description clearly indicates a device used for a surgical procedure within the anal canal, not for laboratory testing of patient specimens.
N/A
Intended Use / 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.
Product codes
FHN, FER
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal-rectal
Indicated Patient Age Range
adult patients only
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)
Not Found
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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K060623
510k Summary
| Name: | Cook Ireland | |
|---|---|---|
| Address: | O' Holloran Road | |
| National Technology Park | ||
| Limerick | ||
| Ireland | SEP - 6 2006 | |
| Phone: | ||
| Fax: | 353 61 334440 | |
| 353 61 334441 | ||
| Contact Person: | Emmett Devereux, Quality & Regulatory | |
| Manager | ||
| Sinead Burke, Regulatory Affairs Specialist | ||
| Date: | August 10, 2006 | |
| Trade Name: | ShortShot Saeed Hemorrhoidal Multi-Band | |
| Ligator with TriView Anoscope | ||
| Common Name: | Hemorrhoidal Multiple Band Ligator | |
| Anoscope | ||
| Classification Name: | Ligator, Hemorrhoidal, GU, 78FHN | |
| Anoscope, 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 polycarbonate | ||
| barrel attached to the tip of a polycarbonate | ||
| handle. 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.
1
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
2
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.
3
Page 2 -
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
4
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__