(82 days)
The family of "THD disposable Anoscope/Proctoscope" is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The family of "THD disposable Anoscope/Proctoscope" are designed for examination and treatment of the anal (Anoscope) and recture (Proctoscope) examination and consists of transparent plastic disposable anoscopes and proctoscopes in sterile and non sterile conditions, for diagnostic or therapeutic use. The family of THD disposable Anoscopes and Proctoscopes is made by 2 categories of devices: Diagnostic Anoscopes and Proctoscopes, Surgical Proctoscopes. Illumination is provided by a PenLight or by the "Shining Light" illuminator both supplied and manufactured by THD Spa. A PenLight is a battery powered illuminator while the "Shining Light" is AC powered. Both of these accessories are light sources employed to optimize the use of the anoscopes and proctoscopes.
The provided text is a 510(k) summary for a medical device, the "THD disposable Anoscope/Proctoscope." This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove device performance against specific acceptance criteria through a clinical study or direct performance testing.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods for performance evaluation.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
- Details on standalone algorithm performance.
- The type of ground truth used for performance evaluation.
- Sample size for a training set or how ground truth for a training set was established, as this is not an AI/ML device.
Instead, the document focuses on:
- Substantial Equivalence: The core of this 510(k) is to demonstrate that the "THD disposable Anoscope/Proctoscope" is substantially equivalent to existing predicate devices (Sapimed Self Light Disposable Anoscope K070913 and Sapimed Disposable Sigmoidoscope/Proctoscope K070915). This is a regulatory pathway that relies on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as the predicate device.
- Device Description: It describes the device's components, variations (diagnostic vs. surgical), and illumination methods.
- Indications for Use: Clearly states the intended purpose for examining the anal sphincter, anus, rectum, and for diagnostic/therapeutic procedures.
- Supporting evidence for safety and identity:
- Shelf Life: Accelerated aging testing was performed to substantiate a 5-year expiration date. (This is a form of performance testing, but not directly related to accuracy or clinical effectiveness in the way an AI would be evaluated).
- Biocompatibility: The devices are compliant with ISO10993 standards. (This is safety testing, not performance criteria for a diagnostic/therapeutic outcome).
In summary, the provided text is a regulatory submission demonstrating substantial equivalence based on device characteristics, intended use, and safety standards, not a performance study as you've outlined for an AI/ML or diagnostic device.
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K080/32
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510(k) Summary for the THD Spa - Family of "THD disposable Anoscope/ Proctoscope"
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | THD SpaVia Industria, 142015 Correggio (RE)Italy | APR 9 2008 | |
|---|---|---|---|
| Contact Person: | Filippo BastiaTHD SpaVia Industria, 142015 Correggio (RE)ItalyTelephone: +39 0522-634311Fax: +39 0522-634371Email: filippo.bastia@thdlab.com | ||
| Consultant in Italy: | Guido BonapaceISENETVia Calindri, 5040068 - S.Lazzaro di Savena (BO)ItalyTelephone: +39-051-625 7315Port.phone: +39-335-537-8686Fax: +39-051-8284344Email: gbonapace@alice.it | ||
| Summary Preparation Date: | 14/01/2008 | ||
| 2. | Names | Device Name: Familiy of “THD disposableAnoscope / Proctoscope” | |
| Classification: | Regulation Description: Endoscope and accessoriesRegulation number: 876.1500Classification name: Anoscope and accessoriesEndoscope, AC-powered andaccessoriesProduct Code: FER/GCP |
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K080132
pg 2 of 2
3. Predicate Devices
The familiy of "THD disposable Anoscope/Proctoscope" are substantially equivalent to a combination of the following devices:
- Sapimed Self Light Disposable Anoscope (K070913)
-
Sapimed Disposable Sigmoidoscope/Proctoscope (K070915)
4. Device Description
The family of "THD disposable Anoscope/Proctoscope" are designed for examination and treatment of the anal (Anoscope) and recture (Proctoscope) examination and consists of transparent plastic disposable anoscopes and proctoscopes in sterile and non sterile conditions, for diagnostic or therapeutic use.
The family of THD disposable Anoscopes and Proctoscopes is made by 2 categories of devices:
- · Diagnostic Anoscopes and Proctoscopes
- Surgical Proctoscopes .
Illumination is provided by a PenLight or by the "Shining Light" illuminator both supplied and manufactured by THD Spa. A PenLight is a battery powered illuminator while the "Shining Light" is AC powered. Both of these accessories are light sources employed to optimize the use of the anoscopes and proctoscopes.
The THD disposable Anoscopes and Proctoscopes and the accessories are equivalent to other legal marketed devices, as Sapimed devices, for classification, intended use, disposability, design characteristics and accessories.
5. Indications for Use
The family of "THD disposable Anoscope/Proctoscope" is intended for physician use to examine the anal sphincter, anus, rectum, and. using additional accessories. to perform various diagnostic and therapeutic procedures.
6. Shelf life
Accelerated aging testing was performed to substantiate an expiration date of 5 years.
7. Biocompatibility testing
The "THD disposable Anoscope/Proctoscope" devices are compliant to the requirements of the ISO10993 standard.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three curved lines representing the eagle's wings and body.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
THD Spa % Mr. Guido Bonapace Consultant ISENET Via Calindri 50 40068 - San Lazzaro di Savena (BO) ITALY
Re: K080132
Trade/Device Name: Family of "THD disposable Anoscope/Proctoscope" Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER and GCF Dated: January 14, 2008 Received: January 18, 2008
Dear Mr. Bonapace:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. The logo appears to be a commemorative emblem for the centennial of the FDA.
Protesting and Promoting 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 (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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely vours.
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): 1680 13 V
Device Name: Family of "THD disposable Anoscope/Proctoscope"
Indications for Use:
The family of "THD disposable Anoscope/Proctoscope" is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
X Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
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(Division of Reproductive, Abdominal, Division ological Devices 080132 510(k) Number.
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§ 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.