The Sapimed Self Ligh®t Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Description

The Sapimed Self Light ® Disposable Anoscopes are clear, transparent plastic anoscopes in a range of sizes to suit varying clinical needs. Illumination is provided by either coldlight source GLF 100 or pen-light. The anoscopes are provided in the following configurations: Models A.4018 and 4019 are clear anscopes for a clear and easy rectal examination. Models A.4023 and 4024 are anoscopes for examination and use in surgical procedures. The Self-Light® Disposable Operating Anoscopes are clear, transparent disposable anoscopes for various proctological procedures. Illumination is provided by either coldlight source GLF 100 or pen-light. Model A.4081 is an operating anoscopes with a curved shape, transparency and length suitable for open and close hemorrhoiectomy, spincterotomy , coleo/ileo anastamosis, anoplasty, etc. Model A.4082 Basile's cone shaped operating anoscope has a graduated scale visible on the internal part of the instrument. ModelA.4083 The Beak is a surgical anoscope with a closed and rounded tip and a fulllength open channel 2-2.5cm wide

AI/ML Overview

The provided text is a 510(k) summary for the Sapimed Self Light Disposable Anoscope. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results typical of clinical efficacy or analytical validation studies for novel devices.

Therefore, many of the requested elements for a performance study (like sample size, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The assessment of this device is based on its similarity to previously cleared devices.

Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, explicit "acceptance criteria" for a performance study in the sense of accuracy, sensitivity, specificity, etc., are not defined because it's a substantially equivalent submission for a physical instrument, not a diagnostic or AI-driven device. The "performance" assessment is based on demonstrating similar fundamental characteristics, intended use, and safety/efficacy to predicate devices.

Acceptance Criteria Category	Specific Criteria (Inferred from submission type)	Reported Device Performance
Intended Use	Must be substantially equivalent to predicate devices.	"The Sapimed Self Light® Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures." Assessment: Identical to predicate device intended uses.
Technological Characteristics	Must demonstrate similar design, material (plastic), single-use nature, packaging (clean, non-sterile/sterile), and illumination method (coldlight source or pen-light). No new questions concerning safety and efficacy.	Description: Clear, transparent plastic anoscopes, various sizes, illumination by coldlight source or pen-light. Models for examination and surgical procedures. Features like curved shape, graduated scale, full-length open channel. Comparison Table: All predicated devices use plastic, are disposable, and are packaged as clean/non-sterile or sterile. Assessment: "The Sapimed disposable anoscopes have a similar intended use, technological characteristics and mode of operation as the predicate products, both disposable and reuseable and presents no new questions concerning safety and efficacy."
Material Safety (Biocompatibility)	Must meet ISO10993 standards.	"ISO10993 standards" (implicitly met or claimed to be met, further details would be in the full submission, not the summary).
Shelf Life	Must have a substantiated expiration date.	"Accelerated aging testing was performed to substantiate an expiration of 5 years."

Regarding the Absence of Performance Study Details:

The provided document is a 510(k) summary for a medical device (anoscope), which is a physical instrument. It is not an AI/ML-driven diagnostic or imaging device. Therefore, a "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics like sensitivity, specificity, accuracy, or reader studies, is generally not required or presented for this type of submission.

The "acceptance criteria" here relate to demonstrating substantial equivalence in terms of intended use, technological characteristics, safety, and physical properties (like material, sterility, shelf life) to legally marketed predicate devices. The "study" that proves this is primarily the comparison to predicates, biocompatibility testing, and shelf-life testing, as mentioned.

Let's address the specific numbered points based on the nature of this submission:

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. This submission does not involve a "test set" or clinical performance data in the typical sense for a diagnostic device. The evaluation is based on engineering principles (material properties, design), biocompatibility testing results (which would involve samples of the device material), and accelerated aging studies (which use samples of the final product). The provenance of data for these engineering tests is generally from the manufacturer's testing facilities (SAPIMED S.P.A., Alessandria, ITALY).

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. No "ground truth" establishment by medical experts for a test set is part of this type of device submission. The safety and effectiveness are established through comparison to predicates and standard engineering/biocompatibility testing managed by qualified laboratory personnel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. No "test set" and thus no adjudication method for expert review of cases.

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 device is a manual, physical instrument, not an AI-driven system. Therefore, no MRMC study was conducted or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. The "ground truth" for the characteristics assessed (e.g., biocompatibility) would be defined by the results of the ISO 10993 tests themselves against established acceptable limits for those tests. For shelf-life, the ground truth is the physical and material integrity of the device over time demonstrated by accelerated aging.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not Applicable. No training set.

Summary

{0}------------------------------------------------

K0709/3

510(k) Summary

SAPIMED S.P.A. Via Santi 25-Z.I. D4 Scalo

Alessandria, ITALY 15100 Phone 39-013-1348109

AUG 1 0 2007

Contact: Mrs. Paola Oddenino

Summary Prepared: February 28, 2007

Trade Name: Sapimed Self Light Disposable Anoscope

Common Name: Disposable Anoscope

Classification Name: Anoscope, Non-Powered Endoscope, AC Powered and Accessories

Predicate Device Identification:

CFR21:876.1500 Product Code:FER/GCP Device Class:II Legally Marketed Device: Company Patrick J. O'Regan Welch Allyn, Inc North EOS Industries

Product 510(k) # O'Regan Disposable Anoscope K020702 Model #53110 Disposable Anoscope K810227 EOS Brand Disposable Proctoscope K954614

Description:

Models A.4018 and 4019 are clear anscopes for a clear and easy rectal examination.

Models A.4023 and 4024 are anoscopes for examination and use in surgical procedures. The Self-Light® Disposable Operating Anoscopes are clear, transparent disposable anoscopes for various proctological procedures. Illumination is provided by either

{1}------------------------------------------------

coldlight source GLF 100 or pen-light.

Pg 2 of 3

Ro70913

Model A.4081 is an operating anoscopes with a curved shape, transparency and length suitable for open and close hemorrhoiectomy, spincterotomy , coleo/ileo anastamosis, anoplasty, etc.

Model A.4082 Basile's cone shaped operating anoscope has a graduated scale visible on the internal part of the instrument.

ModelA.4083 The Beak is a surgical anoscope with a closed and rounded tip and a fulllength open channel 2-2.5cm wide

Intended Use:

The Sapimed Self Light® Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Predicate Product Comparison Chart:

Parameter
Device Name	SapimedDisposableAnoscope	O'ReganDisposableAnoscope	Welch AllynDisposableAnoscope	North EosIndustriesDisposableProctoscope
Product Code	FER	FER	FER	GCP
K Number		K020702	K810227	K954614
CommonName	Disposableanoscope	DisposableAnoscope	Disposableanoscope	Disposableproctoscope
Intended Use	intended forphysician use toexamine the analsphincter and anus,and, usingadditionalaccessories, toperform variousdiagnostic andtherapeuticprocedures.	intended forphysician use toexamine the analsphincter and anus,and, using additionalaccessories, toperform variousdiagnostic andtherapeuticprocedures.	intended forphysician use toexamine the analsphincter and anus,and, using additionalaccessories, toperform variousdiagnostic andtherapeuticprocedures.	intended forphysician use toexamine the analsphincter and anus,and, usingadditionalaccessories, toperform variousdiagnostic andtherapeuticprocedures
Material	Plastic	Plastic	Plastic	Plastic

{2}------------------------------------------------

K 07 0913
Fgj 343

Single use
Packaged	YesClean, non-sterile/Sterile	YesClean, non sterile	YesClean, non-sterile	YesSterile

Similarities and differences between Self-Light Disposable Anoscope and Predicate Products

The Sapimed disposable anoscopes have a similar intended use, technological

characteristics and mode of operation as the predicate products, both disposable and

reuseable and presents no new questions concerning safety and efficacy.

Shelf Life

Accelerated aging testing was performed to substantiate an expiration of 5 years.

Biocompatibility Testing:

ISO10993 standards

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 0 2007

Sapimed S.P.A. c/o Ms. Yoland Smith Consultant Smith Associates 1676 Village Green, Suite A CROFTON MD 21114

Re: K070913

Trade/Device Name: Self Light® Disposable Anoscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: June 1, 2007 . Received: June 28, 2007

Dear Ms. Smith:

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/3/Picture/10 description: The image is a black and white circular seal. The seal commemorates the FDA's centennial from 1906-2006. The center of the seal contains the letters FDA in a bold, blocky font, with the word "Centennial" written in a cursive font underneath.

Protecting and Promoting Public Health

{4}------------------------------------------------

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 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" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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

{5}------------------------------------------------

Indications for Use

Ko70913 510(k) Number (if known):

Device Name: Self Light® Disposable Anoscope

Indications for Use:

Prescription Use ﮮ AND/OR (Part 21 CFR 801 Subpart D)

and Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Reproductive, Abdominal,

Regulation Number and Section

§ 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.