(78 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or related concepts.
No
The device is described as an applicator for inserting suppositories and does not perform any therapeutic function itself. Its purpose is to facilitate the delivery of a therapeutic agent (the suppository), not to provide therapy.
No
The device is described as an applicator for inserting suppositories and does not mention any diagnostic function such as detecting, monitoring, or treating diseases or conditions. Its purpose is purely for delivery, not diagnosis.
No
The device description explicitly states it is a "plastic, non sterile, single use device" with physical components (plunger and barrel), indicating it is a hardware device, not software-only.
Based on the provided information, the InsertEase™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- InsertEase™ Function: The description clearly states that InsertEase™ is a device for the insertion of suppositories into the rectum. It is a physical tool used to deliver a substance into the body.
- No Sample Analysis: There is no mention of InsertEase™ analyzing any biological samples or providing diagnostic information based on such analysis.
Therefore, InsertEase™ falls under the category of a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum
Product codes
876, OOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectum
Indicated Patient Age Range
Not Found
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)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
2
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.
3
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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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
5
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 _