(45 days)
Not Found
No
The device description and performance studies focus on a mechanical device for circumcision and do not mention any AI or ML components or functionalities.
No.
The ShangRing device is indicated for performing circumcision, a surgical procedure, not for treating a disease or condition therapeutically.
No
The device is indicated for performing circumcision, which is a surgical procedure, not a diagnostic one. It is used to excise the foreskin, not to diagnose a condition.
No
The device description clearly states that the ShangRing is a physical device made of polycarbonate and silicone, consisting of two concentric rings. It is a sterile, single-use, disposable circumcision device. There is no mention of any software component.
Based on the provided information, the ShangRing™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the circumcision of adult males, which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical tool used to perform a surgical procedure (circumcision) by mechanically crushing and removing the foreskin.
- Lack of Diagnostic Function: The device does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status, disease, or condition.
- No Mention of Diagnostic Testing: The description focuses entirely on the surgical application of the device.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ShangRing™ device does not fit this description. It is a surgical device.
N/A
Intended Use / Indications for Use
The ShangRing device is indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.
Product codes (comma separated list FDA assigned to the subject device)
HFX
Device Description
The ShangRing is a sterile, single use, disposable circumcision device consisting of two concentric rings made from polycarbonate. The outer ring is formed from two semi-circular halves that are joined together on one end by a hinge, and by interlocking ratchets on the opposite end. The inner ring is lined with a soft silicone band. The ShangRing is available in 14 sizes with inner ring diameters ranging from 26mm to 40mm. A disposable sizing guide is provided to assist in selecting the appropriate size ShangRing. The ShangRing is designed to perform a circumferential crushing of the foreskin (prepuce) between the inner ring and outer ring. The inner ring is placed over the penis, at the level of the coronal sulcus. After local anesthesia, the healthcare practitioner everts the patient's foreskin over the inner ring and the outer ring halves are locked together, sandwiching the foreskin between the two rings which effectively prevents bleeding. Skin forward of the crush line is trimmed away. After the procedure, the ShangRing device remains on the patient for 7 days. After 7 days, the ShangRing is removed by the healthcare practitioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foreskin or prepuce
Indicated Patient Age Range
adult males
Intended User / Care Setting
healthcare practitioner
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)
The ShangRing has been the subjective of extensive clinical evaluations, both in China and Kenya. Approximately 3000 cases in these two countries have been reported in clinical literature. These studies have demonstrated that the ShangRing is easily applied in a short surgical procedure with no suturing required. Adverse events were infrequent, and mild - requiring minimal management. Complication rates were lower than experienced with conventional methods. The clinical data collected confirms that the ShangRing is a safe and effective means of performing circumcision on adult males.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
3 2012 AUG
Trade/Device Name: ShangRingTM Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HFX Dated: June 15, 2012 Received: June 19, 2012
Dear Dr. Nolte:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
AUG 3 2012
5
device-related adverse events) (21 CFR 803); 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.
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,
Benjamin K. Ticho
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
KI21789
Indications for Use
510(k) Number (if known): K121789
ShangRing™ Device Name:
Indications for Use:
The ShangRing™ device is indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.
Prescription Use _x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Lemmer
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121789