(148 days)
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.
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.
Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.
Based on the provided document, the device in question is the Circumplast Circumcision Device.
Here's the analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with specific numerical targets. Instead, it describes various non-clinical tests conducted and their pass status, implying that the acceptance criterion for each test was to pass it.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compression Testing requirements met | Pass |
| Tensile Strength requirements met | Pass |
| Torsion Testing requirements met | Pass |
| Sterilization Testing requirements met | Pass |
| Biocompatibility (ISO 10993-1 for surface device in prolonged contact with intact skin) requirements met | Pass |
| Overall design requirements met | Confirmed |
| Sterilization requirements met | Confirmed |
| Biocompatibility requirements met | Confirmed |
| Output meets design inputs and specifications | Confirmed |
| Safe and Effective (clinical studies) | Demonstrated |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Performance Data: The document does not specify the sample sizes (e.g., number of devices tested) for the Compression, Tensile Strength, Torsion, Sterilization, and Biocompatibility tests. The data provenance is also not explicitly stated in terms of country of origin for these non-clinical tests. They are presented as general lab tests performed to support substantial equivalence.
- Clinical Performance Data:
- Sample Size: Not specified. The document only states "Two clinical studies conducted."
- Data Provenance: England and Australia (retrospective or prospective is not specified, but typically clinical trials are prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document describes non-clinical engineering tests and clinical studies, but it doesn't detail the process of establishing "ground truth" for a test set in the way one might for an AI/diagnostic device. For clinical studies, the "ground truth" would be derived from the patient outcomes and expert medical assessment during the study, but the specifics of how many experts were involved in evaluating these outcomes and their qualifications are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the focus is on non-clinical performance and a general statement about clinical safety and effectiveness, an explicit adjudication method for a "test set" as typically seen in diagnostic device evaluations (e.g., 2+1, 3+1 consensus) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable/provided. The device in question, the Circumplast Circumcision Device, is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or performed for this product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/provided. As explained above, this device is a manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Non-Clinical: The "ground truth" for the non-clinical tests (Compression, Tensile Strength, Torsion, Sterilization) is based on engineering standards and design specifications. For Biocompatibility, the ground truth is established by ISO 10993-1 standards.
- Clinical: The "ground truth" for the clinical studies, where safety and effectiveness were demonstrated, would be based on patient outcomes as assessed by healthcare practitioners in a clinical setting.
8. The Sample Size for the Training Set
This information is not applicable/provided. The concept of a "training set" is usually relevant for machine learning or AI models. For a physical medical device, the "training set" would arguably be the accumulation of engineering design iterations and preliminary testing, but the document doesn't provide specific sample sizes for these development stages.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
{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
{2}------------------------------------------------
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
{3}------------------------------------------------
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 | SignificantDifferences |
|---|---|---|---|
| Trade Name | New DeviceCircumplast | PredicateSmartKlamp | |
| 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-gynecologicspecialized manualinstrument | Obstetric-gynecologicspecialized manualinstrument | N/A |
| Intend Use/Indications for Use | The Circumplast® single usecircumcision device isintended to be used toperform circumcisions oninfant males. | Circumcision of newbornsand older males, definedas circumferentialexcision of the foreskin orprepuce at or near thelevel of coronal sulcus,with minimal amount ofpreputial skin remaining. | Similar; subject device isindicated for use oninfant males whilepredicate is for use onboth newborns and oldermales. |
| Patient population | Infant males | Newborn and older males | Similar; subject devicepatient population is asubset to the predicatedevice. |
| Mechanism ofAction | Circumferential crushing ofthe foreskin (i.e. crush theforeskin between the innertube and outer clamp) | Circumferential crushingof the foreskin (i.e. crushthe foreskin between theinner tube and outerclamp) | None |
Table 5A - Comparison of Characteristics
{5}------------------------------------------------
| ManufacturerTrade Name | Novadien Healthcare | Circumvent BV | SignificantDifferences |
|---|---|---|---|
| New DeviceCircumplast | PredicateSmartKlamp | ||
| 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 devicesizes are a subset of thesizes available for thepredicate device. |
| Material(s) | Bell: plasticLigature: linen | Cylinder: transparentpolycarbonateOuter clamp: nylon | Similar; both devices arecomposed of plastic,however, subject deviceuses ligature for clampingwhile predicate usesnylon outer clamp. |
| Need for suture | No | No | None |
| Additionalinstrumentsneeded | Clamp, scissors | Clamp, scissors | None |
| Device remains onthe patient afterprocedure | Yes, falls off in 3 - 7 days | Yes, removed after 5 days | Similar; devices remain onthe patient within avariance of +/- 2 days. |
| Single Use | Yes | Yes | None |
| Provided Sterile | Yes | Yes | None |
| Complies with ISO10993 | 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
§ 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.