(431 days)
Not Found
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI or ML.
No.
The device is an instrument used during a medical procedure (circumcision) to compress tissue, not to treat or diagnose a disease or condition itself.
No
The device is described as an instrument used in a medical procedure to compress the foreskin, not to diagnose a condition.
No
The device description explicitly details a physical instrument with mechanical components (arm, locking mechanism, lock bar, pin, spot welding point) used to compress tissue. There is no mention of software as part of the device itself.
Based on the provided information, the Konig Mogen Clamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. They are used in vitro (outside the body) to provide information about a person's health. Examples include blood tests, urine tests, and tissue biopsies.
- The Konig Mogen Clamp is a surgical instrument used in vivo (inside the body) during a medical procedure. It is used to physically manipulate tissue (compress the foreskin) during circumcision.
The description clearly states its use as an instrument in a surgical procedure on the foreskin of the penis. This is a direct intervention on the body, not an examination of a specimen.
N/A
Intended Use / Indications for Use
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
Product codes (comma separated list FDA assigned to the subject device)
HFX
Device Description
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
The Konig Mogen Clamp consists of an arm with a locking mechanism in order facilitate compression on the foreskin. The locking mechanism consists of a lock connected to a lock bar using a pin. The clamp is fixed with a spot welding point, which allows for a maximum opening of 2.5 mm. The edges of the closing area are chamfered and rounded to avoid tissue injury.
The Konig Mogen Clamp is a reusable instrument that is provided non-sterilyzed by the user. The Konig Mogen Clamp will be validated for use in pre-vacuum steam sterilization.
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
male infant or child
Intended User / Care Setting
The Konig Mogen Clamp is intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers, by surgeons of proper training and experience.
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)
Biocompatibility, cleaning and sterilization, performance, and physical properties testing was conducted on the Konig Mogen Clamp to demonstrate that the product meets its intended use.
- Biocompatibility Study: ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity, ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances. Results: The Konig Mogen Clamp was non-toxic.
- Cleaning and Sterilization Testing: ISO 17665-1:2006 Moist Heat - Req. for the development, validation, and routine control of a sterilization process for medical devices. ISO 15883-2:2006 Req. and tests for washer-disinfectors employing thermal disinfection for surgical instruments (Used for the cleaning and thermal disinfection for reusable surgical instruments). ANSI/AAMI ST79: 2017 Guide to steam sterilization and sterility assurance in health care facilities. Results: No growth at the end of the incubation period.
- Performance Testing: Custom Grip Test, ASTM E322-12 Standard Test Method For Analysis Of Low-Alloy Steels And Cast Irons By Wavelength Dispersive X-Ray Fluorescence Spectrometry, ASTM F1089-10 Standard Test Method for Corrosion of Surgical Instruments, ASTM E18 - 20 Standard Test Methods for Rockwell Hardness of Metallic Materials. Results: Test articles met the acceptance criteria.
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.
Medicon Mogen Circumcision Clamp K100916
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2022
Medline Industries, Inc. Jennifer Mason Regulatory Affairs Principal Three Lakes Drive Northfield, IL 60093
Re: K212911
Trade/Device Name: Konig Mogen Clamp Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: HFX Dated: October 7, 2022 Received: October 11, 2022
Dear Jennifer Mason:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212911
Device Name Konig Mogen Clamp
Indications for Use (Describe)
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in white, stacked vertically, with a stylized white starburst symbol above it. The background is a solid dark blue color. The logo is simple and clean, with a modern and professional look.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
K212911 Page 1 of 5
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Jenny Ly Regulatory Affairs Specialist Phone: 224-234-7457 Email: jly(@medline.com
Summary Preparation Date September 10, 2021
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Konig Mogen Clamp Proprietary Name: Konig Mogen Clamp Common Name: Circumcision Clamp Classification Name: Clamp, Circumcision Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Product Code: HFX Classification Panel: Obstetrics/Gynecology Regulatory Class: Class II Regulation #: 21 CFR 884.4530
Predicate Device
Medicon Mogen Circumcision Clamp K100916
Device Description
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
4
Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a visual element that suggests energy or innovation.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
K212911 Page 2 of 5
The Konig Mogen Clamp consists of an arm with a locking mechanism in order facilitate compression on the foreskin. The locking mechanism consists of a lock connected to a lock bar using a pin. The clamp is fixed with a spot welding point, which allows for a maximum opening of 2.5 mm. The edges of the closing area are chamfered and rounded to avoid tissue injury.
The Konig Mogen Clamp is a reusable instrument that is provided non-sterilyzed by the user. The Konig Mogen Clamp will be validated for use in pre-vacuum steam sterilization.
Indications for Use
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
The Konig Mogen Clamp is intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers, by surgeons of proper training and experience.
Summary of Technological Characteristics
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Konig Mogen Clamp | Medicon Mogen
Circumcision Clamp | Different |
| 510(k) Reference | N/A | K100916 | Different |
| Product Owner | Medline Industries, Inc. | Medicon | Different |
| Product Code | HFX | HFX | Same |
| Intended Use | The Konig Mogen Clamp
is an instrument used in a
medical procedure to
compress the foreskin of
the penis during
circumcision of a male
infant or child. | The 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. | Same |
| Regulation Number | 21 CFR 884.4530 | 21 CFR 884.4530 | Same |
| Design Features | Clamp and locking bar | Clamp and locking bar | Same |
| Design Configurations | In the open position, the
jaws are designed to
separate to a maximum of
2.5 mm. For safe clamping | In the open position, the jaws
are designed to separate to a
maximum of 2.5 mm. For
safe clamping the Medicon | Same |
| | | | |
| | the Konig 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. | 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. | |
| Materials | Stainless Steel - corrosion
resistant | Stainless Steel- corrosion
resistant | Same |
| Performance
Specifications | Standards ASTM F 899-
09 and ISO 7153-1
Standard Specification for
Stainless Steels for
Surgical Instruments
ASTM E322-12 Standard
Test Method For Analysis
Of Low-Alloy Steels And
Cast Irons By Wavelength
Dispersive X-Ray
Fluorescence
Spectrometry
ASTM F1089-10 Standard
Test Method for Corrosion
of Surgical Instruments
ASTM E18 - 20 Standard
Test Methods for
Rockwell Hardness of
Metallic Materials | Standards ASTM F 899-09
and ISO 7153-1 Standard
Specification for Stainless
Steels for Surgical
Instruments
ASTM F 1089-10 and ISO
13402 Standard
Specifications for resistance
against corrosion and
autoclaving of Surgical
Instruments. | Different |
| Prescription vs. OTC | Prescription | Prescription | Same |
| Contact Durations | Surface Device
Breached or compromised
surface
Limited duration | Surface Device
Breached or compromised
surface
Limited duration | Same |
| Sterile vs. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single Use vs. Reusable | Reusable | Reusable | Same |
| Sterilization Method | Steam sterilization | Steam sterilization | Same |
TARLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
5
Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized starburst symbol to the left of the text. The starburst is white, and the background is a solid blue color. The logo is simple and modern, and the colors are clean and professional.
Medline Industries, Inc. Three Lakes Drive
Northfield, IL 60093
6
Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white starburst or lightning bolt symbol positioned vertically behind the text. The background is a solid dark blue color. The logo is simple and modern, with a clean design.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Summary of Non-Clinical Testing
Biocompatibility, cleaning and sterilization, performance, and physical properties testing was conducted on the Konig Mogen Clamp to demonstrate that the product meets its intended use.
Study | Description | Results |
---|---|---|
Biocompatibility | ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity |
ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances | The Konig Mogen Clamp was non-toxic. |
| Cleaning and Sterilization Testing | ISO 17665-1:2006 Moist Heat - Req. for the development, validation, and routine control of a sterilization process for medical devices.
ISO 15883-2:2006 Req. and tests for washer-disinfectors employing thermal disinfection for surgical instruments (Used for the cleaning and thermal disinfection for reusable surgical instruments)
ANSI/AAMI ST79: 2017 Guide to steam sterilization and sterility assurance in health care facilities | No growth at the end of the incubation period. |
| Performance Testing | Custom Grip Test
ASTM E322-12 Standard Test Method For Analysis Of Low-Alloy Steels And Cast Irons By Wavelength Dispersive X-Ray Fluorescence Spectrometry
ASTM F1089-10 Standard Test Method for Corrosion of Surgical Instruments
ASTM E18 - 20 Standard Test Methods for Rockwell Hardness of Metallic Materials | Test articles met the acceptance criteria. |
Summary of Clinical Testing
Not applicable.
7
Image /page/7/Picture/0 description: The image shows the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, stacked above a white, stylized starburst symbol. The background is a solid blue color, and there is a gray bar on the right side of the image.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
K212911 Page 5 of 5
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Konig Mogen Clamps are as safe and as effective for their intended use as the predicate device, Medicon Mogen Circumcision Clamp, under K100916.