Konig Mogen Clamp

K212911 · Medline Industries, Inc. · HFX · Nov 18, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K212911
• Device Name: Konig Mogen Clamp
• Applicant: Medline Industries, Inc.
• Product Code: HFX · Obstetrics/Gynecology
• Decision Date: Nov 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Manual surgical instrument; used by surgeons in healthcare facilities (hospitals, clinics, surgical centers) for male infant/child circumcision. Device consists of arm with locking mechanism; lock connected to lock bar via pin; spot-welded lock screw prevents loosening. Jaws separate to maximum 2.5 mm; chamfered/rounded edges minimize tissue injury. Device provides mechanical compression of foreskin during procedure. Reusable; requires pre-vacuum steam sterilization by user.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (ISO 10993-5, ISO 10993-17), cleaning/sterilization validation (ISO 17665-1, ISO 15883-2, ANSI/AAMI ST79), and performance testing (grip test, material analysis per ASTM E322-12, corrosion resistance per ASTM F1089-10, and hardness per ASTM E18-20).

Technological Characteristics

Reusable manual surgical instrument; stainless steel construction. Features locking mechanism with spot-welded screw; 2.5 mm maximum jaw opening. Standards: ASTM F 899-09, ISO 7153-1, ASTM E322-12, ASTM F1089-10, ASTM E18-20. Sterilization: pre-vacuum steam.

Indications for Use

Indicated for use in male infants or children undergoing circumcision to compress the foreskin. Intended for use by trained surgeons in healthcare facilities including hospitals, medical clinics, and surgical centers.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medicon Mogen Circumcision Clamp (K100916)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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)

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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: [phone] 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.

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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

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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

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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.

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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.