SHANGRING

K121789 · Wuhu Snna Medical Treatment Appliance Technology C · HFX · Aug 3, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K121789
• Device Name: SHANGRING
• Applicant: Wuhu Snna Medical Treatment Appliance Technology C
• Product Code: HFX · Obstetrics/Gynecology
• Decision Date: Aug 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

ShangRing is a sterile, single-use, disposable circumcision clamp for adult males. Device consists of two concentric polycarbonate rings; inner ring lined with silicone; outer ring features hinge and interlocking ratchets. Healthcare practitioner places inner ring over penis at coronal sulcus; everts foreskin over ring; locks outer ring halves together to sandwich and crush foreskin, preventing bleeding. Excess skin is trimmed. Device remains on patient for 7 days to facilitate healing before removal by practitioner. Benefits include sutureless procedure, reduced complication rates, and ease of application. Used in clinical settings by trained healthcare providers.

Clinical Evidence

Clinical evidence includes literature reviews of approximately 3000 cases in China and Kenya. Studies demonstrate ShangRing is safe and effective for adult male circumcision. Procedure is sutureless, easily applied, and associated with infrequent, mild adverse events. Complication rates were lower than conventional methods.

Technological Characteristics

Materials: Polycarbonate (Lexan) rings, silicone lining. Principle: Circumferential crushing of foreskin via locking plastic rings. Dimensions: 14 sizes (26mm-40mm inner diameter). Single-use, sterile. Mechanical locking mechanism. No software or electronic components.

Indications for Use

Indicated for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Plastibell (pre-amendment device)
• Gomco Circumcision Clamp (Thomas Medical Inc., K926353)
• Smart Klamp (Emergo Group, Inc., K032091)

Submission Summary (Full Text)

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<121789
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## 510(k) Summary for the Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. ShangRing™

(per 21CFR 807.92 and lttp://www.fda.gov/MedicalDeviceRegulationandGuidance/default.htm)

#### 1. SUBMITTER/510(K) HOLDER

Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. 4F Overseas Student Pioneer Park Science Innovation Center Economic & Technology Zone North Yinhu Road Wuhu, Anhui, China 241001

| Contact Person: | Mr. Jian Zhong Shang |
|-----------------|----------------------------------------|
| Telephone: | +(86) 553-5844860 or +(86) 553-5963971 |
| Fax: | +(86) 553-5844880 |

Date Prepared: June 15, 2012

#### 2. DEVICE NAME

| Trade Name: | ShangRing™ |
|-----------------------|----------------------------------------------------------------------------------------------|
| Common Name: | Circumcision clamp |
| Classification Name: | Obstetric-Gynecologic Specialized Manual Instrument, Clamp,<br>Circumcision, 21 CFR 884.4530 |
| Device Class: | Class II |
| Classification Panel: | Obstetrical and Gynecological Panel |
| Product Code: | HFX |

#### 3. PREDICATE DEVICES

- · Plastibell (Hollister, pre-amendment device)
- · Gomco Circumcision Clamp (Thomas Medical Inc., K926353) Type (K926535)
- · Smart Klamp (Emergo Group, Inc., K032091)

#### 4. 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.

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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.

## 5. INDICATION FOR USE/INTENDED USE

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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.

#### 6. TECHNOLOGICAL CHARACTERISTICS

The ShangRing and the predicate devices Plastibell, Gomco, and Smart Klamp all achieve circumcision by isolating the foreskin and applying pressure to form a crush line.

The ShangRing and the Smart Klamp are both constructed from plastic and are designed for the healthcare practitioner to position the foreskin over one component and engage a locking mechanism on a companion component. When the lock is engaged, the foreskin is crushed between plastic components.

The overall design of the predicate Plastibell and Gomco devices is similar. However, for both the Plastibell and Gomco, the foreskin is everted over a bell-shaped component (plastic for Plastibell, stainless steel for Gomco). With the Plastibell device, crushing is accomplished by a piece of string. With the Gomco device, a stainless steel clamp is applied.

#### 7. NON-CLINICAL TESTING

Wuhu Snnda conducted mechanical testing of the ShangRing to (1) determine the force required to pull apart the ShangRing's locking mechanism and (2) measure the force required to pull skin out of the ShangRing when it is in the locked position.

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These tests were conducted to supplement the clinical data collected to demonstrate that while the patient is wearing the ShangRing for the indicated period of time, when exposed to the forces anticipated during normal use conditions, the outer ring will not disengage and that the device will remain in place on the patient.

Finished, sterilized ShangRing devices were tested for biocompatibility according to ISO 10993-1 for a surface device in prolonged contact with intact skin. The results confirm that the ShangRing is biocompatible for its intended use.

### 8. CLINICAL TESTING

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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.

## 9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The ShangRing has the same intended use and similar technological characteristics as the predicate devices. Both the ShangRing and predicate devices achieve circumcision by performing circumferential crushing of the foreskin. Non-clinical testing demonstrates that the ShangRing is biocompatible and possesses the required mechanical strength to prevent bleeding and remain attached to the foreskin for at least 7 days following closure of the locking ring. Clinical studies have demonstrated that the ShangRing is safe and effective for circumcision in the target population.

The data collected confirms that the differences in the design between the ShangRing and the predicate devices do not raise any new issues of safety and effectiveness. The information and data collected support a claim of substantial equivalence of the ShangRing to the specified predicate devices.

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| Regulatory Status<br>Intended Use | ShangRing | Hollister<br>Plastibell | Thomas Medical Inc.<br>Gomco Circumcision Clamp<br>K926535 | Emergo Group, Inc.<br>Smart Klamp®<br>K032091 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed<br>The ShangRing™ device is indicated for<br>circumcision of adult males, defined as<br>circumferential excision of the foreskin or<br>prepuce at or near the level of the coronal<br>sulcus. | Pre-amendment device<br>The plastic bell with handle and string is<br>used to tie off the foreskin or prepuce to<br>stop blood flow such that the excess<br>foreskin forward of the string can be cut off<br>with minimal bleeding. | This clamp is used to hold the foreskin of<br>the penis in place while it is being cut<br>during a circumcision procedure. | The device is indicated for circumcision<br>of newborns and older males, defined as<br>circumferential excision of the foreskin or<br>prepuce at or near the level of the coronal<br>sulcus, with minimal amount of preputial<br>skin remaining. |
| Patient population | Adult males | Newborns to adults | Newborns to adults | Newborns to older males |
| Mechanism of<br>Action | Circumferential crushing of the foreskin<br>(i.c., crush the preputial skin between the<br>outer plastic ring and inner plastic ring) | Circumferential crushing of the foreskin | Circumferential crushing of the foreskin<br>(i.e., crush the preputial skin around the<br>rim of the Gomco bell and an appropriate<br>sized hole in the base plate) | Circumferential crushing of the foreskin<br>(i.e., crush the foreskin between the inner<br>tube and outer clamp) |
| Sizes | 14 sizes (2.6, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3,<br>3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0 cm) | 6 sizes (1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 cm) | 8 sizes (1.1, 1.3, 1.6, 2.1, 2.6, 2.9, 3.2, 3.5<br>cm) | 4 sizes (1.0, 1.3, 1.6, 2.1 cm) |
| Material(s) | Inner and outer rings: Lexan<br>(polycarbonate)<br>Soft lining surrounding inner ring:<br>Silicone | Bell: Plastic<br>String: suture | Stainless steel | Cylinder: transparent polycarbonate<br>Outer clamp: nylon |
| Dorsal incision | Yes, in cases when foreskin is too tight to<br>evert. This may occur in patients without<br>phimosis. | Yes | Yes | No |
| Need for suture | No | No | No | No |
| Additional<br>instruments<br>needed | Clamp, blunt end scissors, surgical<br>scissors, 1/8" or 3 mm flat bladed<br>screwdriver | Clamp, surgical scissors | Clamp, Cold knife | Clamp, scissors |
| Device remains on<br>the patient after<br>procedure | Yes, removed after 7 days | Yes, falls off in 3-7 days* | No | Yes, removed after 5 days** |
| Single Use | Yes | Yes | No | Yes |
| Provided Sterile | Yes | Yes | No | Yes |
| Biocompatibility<br>Established | Yes | Information not available | Information not available | Information not available |
| | http://www.circlist.com/instrstechs/plastibell.html<br>http://smartcircumcision.com/smartklamp_2.html | | | |

'able 5-1. Side-by-Side Comparison of the ShangRing with Predicate Devic

CONFIDENTIAL
Page 5-4

June 15, 2012

ShangRing™, Traditional 510(k)
Wuhu Snnda Medical Treatment Appliance Technology Co.

K121789
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Image /page/4/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

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

Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. % Cynthia J.M. Nolte, Ph.D. Principal Regulatory Consultant Aptiv Solutions 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K121789

> 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

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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 [phone] or [phone] 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

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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