The rectal suppository applicator, to be called, InsertEase™, is a plastic, non sterile, single use device for the insertion of prescription and over the counter suppositories into the rectum. The design of InsertEase™ is substantially equivalent to a vaginal applicator used for inserting vaginal suppositories, creams and tampons. One piece, the plunger, will be movably coupled within a second piece, the barrel. The barrel has an open end to receive and hold a suppository, which is then inserted into the anus. The plunger is then pushed into the barrel and places the suppository within the rectum. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons.

AI/ML Overview

The provided text describes a 510(k) submission for a rectal suppository applicator called "InsertEase™". The core of the submission revolves around demonstrating substantial equivalence to already legally marketed predicate devices, primarily vaginal applicators.

Here's an analysis of the acceptance criteria and the study as described in the document, keeping in mind that the primary "study" is a comparison to predicate devices rather than a traditional clinical trial:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not quantitative performance metrics like sensitivity or specificity. Instead, the acceptance criteria are met if the device demonstrates equivalent:

Acceptance Criteria Category	Predicate Device (Vaginal Applicator)	InsertEase™ (Rectal Suppository Applicator)	Outcome / Performance
Intended Use	Insertion of medication into the vagina.	Insertion of suppositories into the rectum.	Equivalent Function: The document argues that the only difference is the anatomical orifice, and the function of inserting a suppository is the same.
Design	Two-piece, plunger within a barrel, open end to hold suppository.	Two-piece, plunger within a barrel, open end to hold suppository.	Equivalent Design: Described as "substantially equivalent" design.
Materials	Plastic (medical grade)	Plastic (medical grade)	Equivalent Materials: Both are plastic applicators to be extruded using medical grade plastic.
Sterility	Non-sterile (implied for common applicators)	Non-sterile	Equivalent Status: Both are non-sterile.
Single Use	Single use (implied for common applicators)	Single use	Equivalent Status: Both are single use.
Function/Movement	Inserts vaginal suppositories/tampons by pushing plunger.	Inserts rectal suppositories by pushing plunger.	Equivalent Function: "functions in the same way and manner".
Manufacturing Facility	FDA approved manufacturing facility	FDA approved manufacturing facility	Equivalent Compliance: Will be manufactured in an FDA approved facility.
Safety and Effectiveness	Demonstrated by predicate devices.	Not questioned when used as labeled, based on predicate equivalence.	Equivalent Assumed: Safety and effectiveness are not in question due to the similarity in function to established predicate devices.
Classification	Class I (Rectal Applicator, Vaginal Applicator)	Class I	Equivalent Classification: Both are Class I devices.

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of a 510(k) based on substantial equivalence to a physical device. There wasn't a "test set" of performance data generated, but rather a comparison of technical characteristics and intended use.
Data Provenance: The "data" primarily comes from the established regulatory classifications and descriptions of existing predicate devices marketed in the United States (implied by FDA regulation). This is retrospective in the sense that it relies on the known characteristics and regulatory history of pre-existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the sense of expert review of performance, was not established for InsertEase™ using a test set. The "ground truth" for the substantial equivalence claim relies on the established regulatory framework and common understanding of how such applicators function, and their safety/effectiveness as previously determined by the FDA for similar devices.

4. Adjudication method for the test set

Not applicable, as there was no test set or expert adjudication process described for performance evaluation.

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 is a medical device for physical application, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study was conducted or relevant to this submission.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

Predicate Device Characteristics: The established design, materials, intended use, and functional principles of legally marketed vaginal applicators (Product Code: 884.4520(7)) and other relevant devices like Enema Kits (876.5210) and Rectal Dilators (876.5450), and the precedent set by the FDA regarding the Rectal Speculum vs. Vaginal Speculum.
Regulatory Precedent: The FDA's prior determination of substantial equivalence for devices with similar function but different anatomical sites (e.g., vaginal vs. rectal speculums).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device submission.

Summary

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K092829
163

Christcot Medical Company

Section 6: 510(k) Summary

Owner/Contact: Jennifer Davagian Ensign Christcot Medical Company P.O. Box 104 Sudbury, Massachusetts 01776 Telephone: 978-390-3805 Facsimile: 978-261-5079 christcotmedical@gmail.com
DEC - 2 2009

510(k) Summary Preparation Date: September 4, 2009

Proprietary Name: InsertEase™

Common Name: Rectal Suppository Applicator

Classification Name: Rectal Applicator

Device Classification: Class I

Classification Code: 876

Classification Panel: Gastroenterology and Urology

Establishment Registration Number: We do not have an establishment registration number at this time but will register within 30 days of marketing InsertEase™

Legally marketed device to which we are claiming equivalence: The following devices are substantially equivalent predicate devices to InsertEase™ as described in the accompanying documents, which also describe the indications for use of InsertEase™.

. Product Code: 884.4520(7) - Vaginal Applicator (common use - no singular trade name)

"(a)Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following : ... "

"(7) A vaginal applicator is an instrument used to insert medication into the vagina."

Product Code: 876.5210 - Enema Kit (common use - no singular trade name) .

"(a)Identification. An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle

· P.O. Box 104 Sudbury, Massachusetts 01776 Phone 978-390-3805 Fax 978-261-5079

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K092829
2 of 3

510(k) Submission for InsertEaseTM

either directly or via tubing. This device does not include the colonic irrigation system (876.5220)."

Product Code: 876.5450 - Rectal Dilator (common use - no singular trade name) "(a){dentification. A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument."

Device Description: The rectal suppository applicator, to be called, InsertEase™, is a plastic, non sterile, single use device for the insertion of prescription and over the counter suppositories into the rectum. The design of InsertEase™ is substantially equivalent to a vaginal applicator used for inserting vaginal suppositories, creams and tampons. One piece, the plunger, will be movably coupled within a second piece, the barrel. The barrel has an open end to receive and hold a suppository, which is then inserted into the anus. The plunger is then pushed into the barrel and places the suppository within the rectum. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons.

Indication for Use: InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum.

The only difference in indication of use between InsertEase™ and vaginal applicators (884.4520(7)) is the anatomical orifice of the body. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons. The difference between a vaginal suppository applicator and rectal suppository applicator is insignificant, and neither safety nor effectiveness of either device is in question when used as labeled. The alternative to both vaginal and rectal suppository applicators is the use of the finger (digital insertion), which is mimicked by both devices.

The FDA has previously addressed this difference and set precedence in the case of the Rectal Speculum (876.4730), which is deemed substantially equivalent to the vaginal speculum (884.4520(3)). Both devices are Class I devices and have the same intended use in different orifices of the body.

Technical Characteristics: Technological characteristics of InsertEase™ compared to the vaginal applicator (predicate device) are the same except for the length. The length of InsertEase™ is slightly longer than that of a vaginal applicator. InsertEase™ is a two piece plastic applicator to be extruded using medical grade plastic in an FDA approved manufacturing facility according to the Medical Device Registration and Listing requirements, which is the same as vaginal applicators currently available. The movement and function of InsertEase™ is equivalent to that of vaginal applicators.

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U.S. Food & Drug Administration

510(k) Submission for InsertEase™

Conclusion: The device InsertEase™ is substantially equivalent to the Substantially Equivalent Predicate Devices listed above and should be granted pre-market approval, as it will help hundreds of thousands of chronic and critically ill patients who must take rectal suppositories.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

DEC - 2 2009

Ms. Jennifer D. Ensign President Christcot Medical Company P.O. Box 104 SUDBURY MA 01776

Re: K092829

Trade/Device Name: InsertEase ™ Regulation Number: 21 CFR §876.4730 Regulation Name: Manual gastroenterology-urology surgical instrument and accessories Regulatory Class: I Product Code: OOW Dated: September 4, 2009 Received: September 14, 2009

Dear Ms. Ensign:

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 (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 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); medical device reporting (reporting of medical

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Page 2 -

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5: Statement of Indications for Use
510(k) Number (if known): K092829

Device Name: InsertEase™

Indications for Use: InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum

(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

Regulation Number and Section

§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.

(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.