(148 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any software-driven functionality.
No
The device is used to perform circumcisions, which is a surgical procedure, not a therapeutic treatment for a disease or condition.
No
The device description clearly states its purpose is to "perform circumcisions on infant males" by performing "circumferential crushing of the foreskin". There is no mention of it being used to diagnose a medical condition or disease.
No
The device description clearly states it is composed of two physical components: a transparent plastic conic tube and a linen ligature. It is a physical medical device used for a surgical procedure.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Circumplast Function: The Circumplast device is a surgical tool used to perform a physical procedure (circumcision) directly on the patient's body. It does not analyze any biological samples.
The description clearly states its purpose is to "perform circumcisions on infant males" by physically manipulating the foreskin. This falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
HFX
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foreskin (prepuce)
Indicated Patient Age Range
infant 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)
Two clinical studies conducted in England and Australia, respectively, demonstrated that the subject device is safe and effective.
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.
SmartKlamp (Circumvent BV, K032091)
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
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: +61 416 178 617 Fax: +61 297 067 888 Contact: Milad Melhem, Chief Executive Officer (CEO) Email: milad.melhem@novadien.com
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (561) 305.5075 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Diane Sudduth, Senior Consultant, QA Email: project.management@emergogroup.com
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.
4
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
Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | New Device
Circumplast | Predicate
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
specialized manual
instrument | Obstetric-gynecologic
specialized manual
instrument | N/A |
| Intend Use/
Indications for Use | The Circumplast® single use
circumcision device is
intended to be used to
perform circumcisions on
infant males. | Circumcision of newborns
and older males, defined
as circumferential
excision of the foreskin or
prepuce at or near the
level of coronal sulcus,
with minimal amount of
preputial skin remaining. | Similar; subject device is
indicated for use on
infant males while
predicate is for use on
both newborns and older
males. |
| Patient population | Infant males | Newborn and older males | Similar; subject device
patient population is a
subset to the predicate
device. |
| Mechanism of
Action | Circumferential crushing of
the foreskin (i.e. crush the
foreskin between the inner
tube and outer clamp) | Circumferential crushing
of the foreskin (i.e. crush
the foreskin between the
inner tube and outer
clamp) | None |
Table 5A - Comparison of Characteristics
5
| Manufacturer
Trade Name | Novadien Healthcare | Circumvent BV | Significant
Differences |
|-----------------------------------------------------|----------------------------------|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | New Device
Circumplast | Predicate
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
sizes are a subset of the
sizes available for the
predicate device. |
| Material(s) | Bell: plastic
Ligature: linen | Cylinder: transparent
polycarbonate
Outer clamp: nylon | Similar; both devices are
composed of plastic,
however, subject device
uses ligature for clamping
while predicate uses
nylon outer clamp. |
| Need for suture | No | No | None |
| Additional
instruments
needed | Clamp, scissors | Clamp, scissors | None |
| Device remains on
the patient after
procedure | Yes, falls off in 3 - 7 days | Yes, removed after 5 days | Similar; devices remain on
the patient within a
variance of +/- 2 days. |
| Single Use | Yes | Yes | None |
| Provided Sterile | Yes | Yes | None |
| Complies with ISO
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.
6
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