(199 days)
Dilation of the anal sphincter and canal for the relief of hemorrhoidal pain and itching, reduction of bleeding, and promotion of healing of inflamed hemorrhoidal tissues.
The Anokryo Dilator consists of a narrow tapered shaft approximately 2.75 inch long and 0.5 inch wide. The hollow interior of the shaft is filled with hydroxyethylcellulose solution before the shaft is molded to a flange knob which serves as a handle The shaft and flange are composed of polyethylene. The device is supplied clean and non-sterile in a plastic storage container and a water-soluble lubricant gel. Prior to use, the rod is stored in its container for 1-2 hours and then moistened with the lubricant gel. A maximum low temperature of -15 degrees C is obtained and sustained for 10 minutes. The device is easily cleaned with detergent and water and stored in its container for reuse.
This document is a 510(k) premarket notification for a rectal dilator device named Anokryo. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full clinical study with acceptance criteria and performance data in the way a novel, higher-risk device might.
Therefore, many of the requested details about acceptance criteria, specific study design elements, and performance metrics are not available in the provided text. The submission relies on the established safety and effectiveness of its predicate devices, rather than a de novo clinical trial with defined endpoints and acceptance thresholds for this specific device.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" and quantifiable "reported device performance" (e.g., sensitivity, specificity, accuracy) are not detailed for the Anokryo device itself. The primary "performance" assertion is that it is "safe and effective for its intended use and performs at least as well as the legally marketed predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The implicit criterion is "Substantial Equivalence" to predicate devices. | "The Anokryo Dilator is similar in design and identical in function and intended use to legally marketed rectal dilators such as the Anurex and Inamed Rhemo-D devices." |
| Implicitly, device must effectively achieve: - Dilation of the anal sphincter and canal - Relief of hemorrhoidal pain and itching - Reduction of bleeding - Promotion of healing of inflamed hemorrhoidal tissues | "Accordingly, MK Conquest International, Inc. has concluded that the Anokryo Dilator is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set or clinical study for the Anokryo device. Its submission is based on comparison to predicate devices, not on new clinical data. Therefore, sample size and data provenance are not applicable in the context of a new study for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no described test set or ground truth established by experts for a study of the Anokryo device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no described test set that would require an adjudication method.
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 physical medical device (rectal dilator), not an AI-based diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new clinical study with ground truth establishment for the Anokryo device is described. The basis for safety and effectiveness is substantial equivalence to predicate devices, which would have had their own historical evidence.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set is relevant to this device's submission.
{0}------------------------------------------------
264634
510 (k) SUMMARY
JUN - 6 1997
1. ADMINISTRATIVE
Submitter: MK Conquest International, Inc. 4201 N. Main Street, Suite 220-G Fort Worth, Texas 76106
Contact Person: Eric Kudimi (817) 625-6565
Date Prepared: March 21, 1997
11. DEVICE NAME
Proprietary Name: Anokryo Common Name: Rectal Dilator
Requlatory Class: Class I 78FFP Product Code:
PREDICATE DEVICES lll.
Commercially available rectal dilators such as the Anurex (K862490) and the Inamed Rhemo-D (K894618).
IV. DEVICE DESCRIPTION
The Anokryo Dilator consists of a narrow tapered shaft approximately 2.75 inch long and 0.5 inch wide. The hollow interior of the shaft is filled with hydroxyethylcellulose solution before the shaft is molded to a flange knob which serves as a handle The shaft and flange are composed of polyethylene.
The device is supplied clean and non-sterile in a plastic storage container and a water-soluble lubricant gel. Prior to use, the rod is stored in its container for 1-2 hours and then moistened with the lubricant gel. A maximum low temperature of -15" C is obtained and sustained for 10 minutes. The device is easily cleaned with detergent and water and stored in its container for reuse.
{1}------------------------------------------------
V. INTENDED USE
Dilation of the anal sphincter and canal for the relief of hemorrhoidal pain and itching, reduction of bleeding, and promotion of healing of inflamed hemorrhoidal tissues.
COMPARISON TO PREDICATE DEVICES VI.
The Anokryo Dilator is similar in design and identical in function and intended use to legally marketed rectal dilators such as the Anurex and Inamed Rhemo-D devices.
Accordingly, MK Conquest International, Inc. has concluded that the Anokryo Dilator is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
President MK Conquest International, Inc. Fort.Worth Meacham Airport JUN - 6 1997 Terminal Building __ ___________ 4201 N. Main Street, Suite 220-G Fort Worth, Texas 76106-2747 Re: K964634 Anokryo Rectal Dilator Dated: March 21, 1997 Received: March 24, 1997 Requlatory class: I 21 CFR §876.5450/Product codes: 78 FFP and LKX
Dear Mr. Kudimi:
Mr. Eric Kudimi
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 You may, therefore, market the device, subject to the general controls (Act). provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions aqainst 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 895, A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: Ceneral (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
{3}------------------------------------------------
Page 2 - Mr. Eric Kudini
This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97) . be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Robert v. Sutting/
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
of 1 Page 1
| 510(k) Number (if known): | K964634 |
|---|---|
| Device Name: | Anokryo |
Indications for Use:
- Dilation of the anal sphincter and canal for the relief of hemorrhoidal 华 pain and itching, reduction of bleeding, and promotion of healing of inflamed hemorrhoidal tissues.
(PLEASE DO NOT WRITE BLIGW THIS LINE CONTINUE ON ANDTHER PAGE II NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R Ratliff/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
() ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( )
Over-the-Counter Use /
(Optional Format 1 2 96)
§ 876.5450 Rectal dilator.
(a)
Identification. 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.(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.