Konig Mogen Clamp

{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<br>Analysis | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Product Name | Konig Mogen Clamp | Medicon Mogen<br>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<br>is an instrument used in a<br>medical procedure to<br>compress the foreskin of<br>the penis during<br>circumcision of a male<br>infant or child. | The Mogen Circumcision<br>Clamp is an instrument used<br>in a medical procedure to<br>compress the foreskin of the<br>penis during circumcision of<br>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<br>jaws are designed to<br>separate to a maximum of<br>2.5 mm. For safe clamping | In the open position, the jaws<br>are designed to separate to a<br>maximum of 2.5 mm. For<br>safe clamping the Medicon | Same | | | | | | | | the Konig Mogen Clamp<br>is locked with a defined<br>closing force. For safety<br>reasons, the lock screw of<br>the clamp is fixed with a<br>spot welding point in<br>order not to become loose. | Mogen Clamp is locked with<br>a defined closing force. For<br>safety reasons, the lock<br>screw of the clamp is fixed<br>with a spot welding point in<br>order not to become loose. | | | Materials | Stainless Steel - corrosion<br>resistant | Stainless Steel- corrosion<br>resistant | Same | | Performance<br>Specifications | Standards ASTM F 899-<br>09 and ISO 7153-1<br>Standard Specification for<br>Stainless Steels for<br>Surgical Instruments<br>ASTM E322-12 Standard<br>Test Method For Analysis<br>Of Low-Alloy Steels And<br>Cast Irons By Wavelength<br>Dispersive X-Ray<br>Fluorescence<br>Spectrometry<br>ASTM F1089-10 Standard<br>Test Method for Corrosion<br>of Surgical Instruments<br>ASTM E18 - 20 Standard<br>Test Methods for<br>Rockwell Hardness of<br>Metallic Materials | Standards ASTM F 899-09<br>and ISO 7153-1 Standard<br>Specification for Stainless<br>Steels for Surgical<br>Instruments<br>ASTM F 1089-10 and ISO<br>13402 Standard<br>Specifications for resistance<br>against corrosion and<br>autoclaving of Surgical<br>Instruments. | Different | | Prescription vs. OTC | Prescription | Prescription | Same | | Contact Durations | Surface Device<br>Breached or compromised<br>surface<br>Limited duration | Surface Device<br>Breached or compromised<br>surface<br>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<br><br>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.<br><br>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)<br><br>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<br><br>ASTM E322-12 Standard Test Method For Analysis Of Low-Alloy Steels And Cast Irons By Wavelength Dispersive X-Ray Fluorescence Spectrometry<br><br>ASTM F1089-10 Standard Test Method for Corrosion of Surgical Instruments<br><br>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.