(248 days)
Not Found
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI/ML terms or data-driven performance metrics.
No
The device is described as an instrument used to compress the foreskin during circumcision, which is a surgical procedure, not a therapeutic treatment for a medical condition.
No
Explanation: The device is a surgical instrument used to compress the foreskin during circumcision, not to diagnose a condition.
No
The device description clearly states it is a stainless steel, reusable circumcision clamp with multiple physical components, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Function: The Medicon Mogen Circumcision Clamp is a surgical instrument used during a medical procedure on the body. It is a tool for physically manipulating tissue.
- Lack of Diagnostic Testing: The description does not mention any testing of samples or providing diagnostic information. Its purpose is purely procedural.
The information provided clearly describes a surgical instrument, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medicon Mogen Circumcision Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.
Product codes (comma separated list FDA assigned to the subject device)
HFX
Device Description
The Medicon Mogen Circumcision Clamp is a stainless steel, reusable circumcision clamp consisting out of multiple components, including clamp and locking bar. For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose. For safety reasons the clamp opens to a maximum of 2.5 mm, in order not to trap the glans and the edges of closing area are chamfered and rounded inside and outside to avoid injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Penis / Foreskin
Indicated Patient Age Range
Infant or child (male)
Intended User / Care Setting
Surgeons of proper training and experience in healthcare facilities, including hospitals, medical clinics and surgical centers.
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)
Non-Clinical Testing was performed:
- Sterilization validation
- Performance testing mechanical, material, and corrosion resistance testing
The Medicon Mogen Circumcision Clamp has been tested and complies with the Standards ASTM F 899-09 and ISO 7153-1 Standard Specification for Stainless Steels for Surgical Instruments and with ASTM F 1089-10 and ISO 13402 Standard Specifications for resistance against corrosion and autoclaving of Surgical Instruments. The test results demonstrate that mechanical performance characteristics, material properties, corrosion resistance and sterilizations of the device are substantially equivalence to the Predicate Device.
Clinical Testing was not performed in order to establish substantial equivalence as this type of technology and procedure has a long history of clinical use.
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
Image /page/0/Picture/0 description: The image shows a collection of medical instruments categorized by type. The categories include implants, instruments, endoscopes, laryngoscopes, and containers. The image also includes the text "K100916" at the top right.
MEDICON &G * Postlach 44 55 * D-78609 Tuttlinger
Medicon
Instrumente
the art of surgery
- B-78500 Tit
DEC - 6 2010
Traditional 510 (k) - HFX
2. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Medicon Mogen Circumcision Clamp
MEDICON eG
(As required by Section 807.92)
- 2.1 Submitter: (807.92 (a) (1))
MEDICON eG Gaensaecker 15 D-78532 Tuttlingen Germany
Tel. +49 7462 2009 0 Fax: +49 7462 200950 eMail: sales@medicon.de
-
2.2 Contact Person:
Joachim Schmid CEO +49 7462 2009 0 Tel. -
Date Summary Prepared: (807.92 (a) (1)) 2.3
December 1, 2010
Page 5 of 17
1
MEDICON eG
Traditional 510 (k) - HFX
2.4 Device Names: (807.92 (a) (2))
| Proprietary Name: | Medicon Mogen Circumcision Clamp |
|---|---|
| Common name: | Mogen Clamp, Mogen Circumcision Clamp, |
| Medicon Mogen Clamp, Circumcision Clamp, | |
| Classification Name: | Clamp, Circumcision |
| Medical Specialty: | Obstetrics/Gynecology |
| Product Code(s): | HFX |
| Regulation Number: | 884.4530 |
| Device Class: | 2 |
-
2.5 Reason for Submission: (807.81(2))
New Device. -
2.6 Predicate Device: (807.92(a)(3))
- T. S. Medical Circumcision Clamp, K033403
2.7 Device Description:
The Medicon Mogen Circumcision Clamp is a stainless steel, reusable circumcision clamp consisting out of multiple components, including clamp and locking bar. For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose. For safety reasons the clamp opens to a maximum of 2.5 mm, in order not to trap the glans and the edges of closing area are chamfered and rounded inside and outside to avoid injuries
- 2.8 Intended Use: (807.92 (a) (5))
The Medicon Mogen Circumcision Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant or child.
2
K100916
MEDICON eG
Traditional 510 (k) - HFX
2.9 Description of Device Function:
Opening of the Medicon Mogen Circumcision Clamp:
Image /page/2/Picture/5 description: The image contains two objects labeled with numbers. Object 1 is on the left side of the image and has a curved shape with an arrow pointing to the left. Object 2 is on the right side of the image and has a more complex shape with multiple sections.
(1) By lifting the clamping lever and turning away of flap, the clamp can be opened (2);
Closing and locking of the Medicon Mogen Circumcision Clamp:
Image /page/2/Picture/8 description: The image shows a black and white picture with two numbers, 3 and 4, with arrows pointing to different parts of the image. The number 3 is on the left side of the image, and the arrow points to the left side of the object. The number 4 is on the top right side of the image, and the arrow points to the top of the object.
(2) By putting the flap against the clamp, the clamp can be closed (4) and locked with the lamping lever;
3
MEDICON eG
Traditional 510 (k) - HFX
2.10 Environment of Use:
The Medicon Mogen Circumcision Clamp is intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers, by surgeons of proper training and experience.
2.11 Sterility Information:
The Medicon Mogen Circumcision Clamp is offered non-sterile for autoclave steam sterilization by user.
2.12 Comparison with SE Device: (807.92 (a) (6))
Based on the information provided in the predicate 510(k) summary, the predicate device is identical to the Medicon Mogen Circumcision Clamp in indications for use, operating principle, design and material. The Medicon Mogen Circumcision Clamp technical information, intended use and performance information, as provided in this premarket notification, shows the subject device to be as safe and effective as the current legally marketed predicate device.
2.13 Summary of physical and performance characteristics
The Medicon Mogen Circumcision Clamp is made out of stainless steel. The stainless steel used is in accordance with the standards ASTM F 899 and ISO 7153-1. All components of the clamp are corrosion resistant.
The Medicon Mogen Circumcision Clamp is supplied non-sterile but is intended to be reused. Decontamination, cleaning and moist heat sterilization has to be performed according to the general instructions described in the package insert prior to each use.
In the open position, the jaws are designed to separate to a maximum of 2.5 mm. For safe clamping the Medicon Mogen Clamp is locked with a defined closing force.
For safety reasons the lock screw of the clamp is fixed with a spot welding point in order not to become loose.
4
K1008916
Traditional 510 (k) - HFX
2.14 Discussion of Non-Clinical Laboratory Tests
The following Non-Clinical Testing was performed:
- o Sterilization validation
- Performance testing mechanical, material, and corrosion resistance o testing
The Medicon Mogen Circumcision Clamp is identical to the Predicate Device in intended use and basic design. The materials used are the same or similar as that used to manufacture the Predicate Device. The Medicon Mogen Circumcision Clamp has been tested and complies with the Standards ASTM F 899-09 and ISO 7153-1 Standard Specification for Stainless Steels for Surgical Instruments and with ASTM F 1089-10 and ISO 13402 Standard Specifications for resistance against corrosion and autoclaving of Surgical Instruments. The test results demonstrate that mechanical performance characteristics, material properties, corrosion resistance and sterilizations of the device are substantially equivalence to the Predicate Device.
2.15 Discussion of Clinical Tests
Clinical Testing was not performed in order to establish substantial equivalence as this type of technology and procedure has a long history of clinical use.
2.16 Conclusions
The Medicon Mogen Circumcision Clamp is substantial equivalence to the Predicate Device and it is as safe and effective for its intended use as the Predicate Device.
5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Joachim Schmid CEO Medicon eG Gansacker 15 78532 Tuttlingen GERMANY
DEC - 6 2010
Re: K100916
Trade/Device Name: Medicon Mogen Clamp
Regulation Number: 21 CFR 8884.4530
Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HFX Dated: November 8, 2010 Received: November 16, 2010
Dear Mr. Schmid:
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 of medical device-related
6
Page 2
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,
Hubert Lehman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
7
INDICATIONS FOR USE
DEC - 6 2010
510(k) Number (if known):
100916
Device Name: Medicon Mogen Circumcision Clamp
Indications For Use:
The Medicon Mogen Circumcision Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during circumcision of a male infrant or child.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hula Semen
(Division Sign-Off) i wision of Reproductive, Abdominal and Faciliogical Devices 510(k) Number _