Circumplast Circumcision Device

K151095 · Novadien Healthcare · HFX · Sep 18, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K151095
• Device Name: Circumplast Circumcision Device
• Applicant: Novadien Healthcare
• Product Code: HFX · Obstetrics/Gynecology
• Decision Date: Sep 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.

Device Story

Circumplast is a single-use, sterile circumcision device consisting of a transparent plastic conic tube and a linen ligature. Used by healthcare practitioners in a clinical setting. The inner ring is placed over the penis at the coronal sulcus; the foreskin is fixed over the ring; the ligature is tied tightly around the groove of the bell to perform circumferential crushing of the foreskin. Excess skin is trimmed. The device remains on the patient for 3-7 days before falling off. The device facilitates the circumcision procedure by providing a mechanical clamp and ligature system to achieve hemostasis and tissue separation, potentially simplifying the procedure and improving patient outcomes.

Clinical Evidence

Two clinical studies conducted in England and Australia demonstrated the safety and effectiveness of the device. No specific performance metrics (e.g., complication rates) were provided in the summary.

Technological Characteristics

Device consists of a plastic conic tube (bell) and a linen ligature. Available in four sizes (0.95, 1.1, 1.2, 1.3 cm). Operates via mechanical circumferential crushing. Provided sterile for single use. Complies with ISO 10993 for biocompatibility.

Indications for Use

Indicated for infant males undergoing circumcision.

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

• SmartKlamp (K032091)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

September 18, 2015

Novadien Healthcare % Diane Sudduth Sr. Regulatory Consultant Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K151095

> Trade/Device Name: Circumplast Circumcision Device Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HFX Dated: August 11, 2015 Received: August 19, 2015

Dear Diane Sudduth,

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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner" in a bold, sans-serif font. Below the name, there is a "-S". In the background, there is a faint, stylized FDA logo, which is partially obscured by the text.

for 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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## 1. Submission Sponsor

Novadien Healthcare Postal Address: PO BOX 1318, Burwood NSW 1805, Australia Physical Address: 14/60 Belmore Street, Burwood NSW 2134, Australia Phone: [phone] Fax: [phone] Contact: Milad Melhem, Chief Executive Officer (CEO) Email: [e-mail]

# 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: [phone] Office Phone: [phone] Fax: [phone] Contact: Diane Sudduth, Senior Consultant, QA Email: [e-mail]

#### 3. Date Prepared

September 18, 2015

#### 4. Device Identification

| Trade/Proprietary Name: | Circumplast circumcision device |
|----------------------------|-----------------------------------------------------|
| Common/Usual Name: | Circumcision clamp |
| Classification Name: | Obstetric-gynecologic specialized manual instrument |
| Classification Regulation: | 21 CFR 884.4530 |
| Product Code: | HFX |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology Panel |

#### 5. Legally Marketed Predicate Device(s)

SmartKlamp (Circumvent BV, K032091)

#### 6. Device Description

The Circumplast is a device composed of two components, a transparent plastic conic tube, and a linen ligature. The device is sold sterile for single use, packaged in a sterile pouch.

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The Circumplast is available in four (4) sizes, to accommodate size of the infant's penis.

The Circumplast 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 fixes the patient's foreskin over the inner ring and then the prepuce is tied all around, over the groove of the bell, with a tight ligature. Skin forward of the crush line is trimmed away.

After the procedure, the Circumplast device remains on the patient for 7 days. The Circumplast falls off after 3 - 7 days.

#### 7. Indication for Use

The Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.

# 8. Substantial Equivalence Discussion

The following table compares the Circumplast to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | Novadien Healthcare | Circumvent BV | Significant<br>Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | New Device<br>Circumplast | Predicate<br>SmartKlamp | |
| 510(k) Number | Not assigned | K032091 | N/A |
| Product Code | HFX | HFX | N/A |
| Regulation Number | 884.4530 | 884.4530 | N/A |
| Regulation Name | Obstetric-gynecologic<br>specialized manual<br>instrument | Obstetric-gynecologic<br>specialized manual<br>instrument | N/A |
| Intend Use/<br>Indications for Use | The Circumplast® single use<br>circumcision device is<br>intended to be used to<br>perform circumcisions on<br>infant males. | Circumcision of newborns<br>and older males, defined<br>as circumferential<br>excision of the foreskin or<br>prepuce at or near the<br>level of coronal sulcus,<br>with minimal amount of<br>preputial skin remaining. | Similar; subject device is<br>indicated for use on<br>infant males while<br>predicate is for use on<br>both newborns and older<br>males. |
| Patient population | Infant males | Newborn and older males | Similar; subject device<br>patient population is a<br>subset to the predicate<br>device. |
| Mechanism of<br>Action | Circumferential crushing of<br>the foreskin (i.e. crush the<br>foreskin between the inner<br>tube and outer clamp) | Circumferential crushing<br>of the foreskin (i.e. crush<br>the foreskin between the<br>inner tube and outer<br>clamp) | None |

Table 5A - Comparison of Characteristics

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| Manufacturer<br>Trade Name | Novadien Healthcare | Circumvent BV | Significant<br>Differences |
|-----------------------------------------------------|----------------------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | New Device<br>Circumplast | Predicate<br>SmartKlamp | |
| Sizes | 4 sizes (0.95, 1.1, 1.2, 1.3 cm) | 4 sizes (1.0,1.3,1.6,2.1 cm) | Similar; subject device<br>sizes are a subset of the<br>sizes available for the<br>predicate device. |
| Material(s) | Bell: plastic<br>Ligature: linen | Cylinder: transparent<br>polycarbonate<br>Outer clamp: nylon | Similar; both devices are<br>composed of plastic,<br>however, subject device<br>uses ligature for clamping<br>while predicate uses<br>nylon outer clamp. |
| Need for suture | No | No | None |
| Additional<br>instruments<br>needed | Clamp, scissors | Clamp, scissors | None |
| Device remains on<br>the patient after<br>procedure | Yes, falls off in 3 - 7 days | Yes, removed after 5 days | Similar; devices remain on<br>the patient within a<br>variance of +/- 2 days. |
| Single Use | Yes | Yes | None |
| Provided Sterile | Yes | Yes | None |
| Complies with ISO<br>10993 | Yes | Yes | None |

## 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of Circumplast and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Novadien completed a number of tests.

The following testing has been performed to support substantial equivalence:

- . Compression Testing - Pass
- Tensile Strength - Pass
- Torsion Testing - Pass
- Sterilization Testing Pass ●

Finished, sterilized 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 Circumplast device and ligature are biocompatible for its intended use.

The Circumplast device meets all the requirements for overall design, sterilization and biocompatibility confirms that the output meets the design inputs and specifications. The Circumplast passed all testing stated above as shown by the acceptable results obtained.

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# 10. Clinical Performance Data

Two clinical studies conducted in England and Australia, respectively, demonstrated that the subject device is safe and effective.

# 11. Statement of Substantial Equivalence

The differences between the Circumplast and the predicate devices cited do not raise any different questions regarding safety and effectiveness. The differences in the technological characteristics are minimal, and the associated procedures are nearly identical. The indications for use are identical to the indications of one of the previously cleared predicate devices. The device, as designed and manufactured, is as safe and effective as the predicate devices, and the device is substantially equivalent to the referenced predicate devices