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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Konig Mogen Clamp. This submission is for demonstrating substantial equivalence to a predicate device, not for establishing clinical efficacy or safety from scratch through the rigorous testing typically performed for novel devices or AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested about acceptance criteria, study details (sample size, data provenance, expert ground truthing, MRMC studies, standalone performance, training set details) that would be relevant for an AI/SaMD device.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing for physical performance, biocompatibility, and cleaning/sterilization validation, as detailed in the "Summary of Non-Clinical Testing" section.

Here's a breakdown based on the provided document, highlighting why most of the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary of non-clinical tests. The "Acceptance Criteria" for this type of device are typically met by passing standard international and ASTM (American Society for Testing and Materials) tests for surgical instruments. The "Reported Device Performance" is stated as "Test articles met the acceptance criteria" and "The Konig Mogen Clamp was non-toxic," and "No growth at the end of the incubation period." Specific numerical results or detailed acceptance ranges are not provided in this summary.

Study	Description	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	ISO 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro CytotoxicityISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances	Must demonstrate non-toxicity and allowable limits for leachable substances as per ISO 10993 standards.	"The Konig Mogen Clamp was non-toxic." (Implies compliance with ISO 10993)
Cleaning & Sterilization	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	Must be effectively cleaned and sterilized to achieve sterility assurance level (SAL). No microbial growth after sterilization.	"No growth at the end of the incubation period." (Confirms successful sterilization to required standards)
Performance Testing	Custom Grip TestASTM E322-12 Standard Test Method For Analysis Of Low-Alloy Steels And Cast Irons By Wavelength Dispersive X-Ray Fluorescence SpectrometryASTM F1089-10 Standard Test Method for Corrosion of Surgical InstrumentsASTM E18 - 20 Standard Test Methods for Rockwell Hardness of Metallic Materials	Material composition, grip force, corrosion resistance, and hardness must meet specified ASTM standards for surgical instruments to ensure durability and proper function.	"Test articles met the acceptance criteria." (Confirms compliance with specified ASTM standards and custom grip test requirements, although specific values are not provided)

2. Sample size used for the test set and the data provenance:

This document describes non-clinical bench testing for a physical surgical instrument. The "test set" would refer to the number of physical clamps subjected to the various physical, chemical, and sterilization tests. The document does not specify the exact number of units tested.

Sample Size: Not specified for non-clinical tests. Medical device bench testing for performance and cleaning/sterilization typically involves a representative sample size of devices, often in the range of 3-30 units, depending on the test and statistical considerations.
Data Provenance: Not applicable in the sense of patient data. The tests are performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in the context of this device's testing refers to objective measurements against engineering standards (e.g., material composition, hardness, successful sterilization, resistance to corrosion) rather than expert interpretation of patient data. These tests are performed by technicians or engineers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This refers to establishing consensus among human readers for diagnostic tasks, which is not relevant for this type of device's non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This type of study is relevant for AI or diagnostic imaging devices that assist human readers. The Konig Mogen Clamp is a manual surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This refers to the performance of an AI algorithm, not a manual surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's non-clinical testing is based on:

Pre-defined engineering specifications and ASTM/ISO standard requirements (e.g., chemical composition, hardness values, corrosion resistance, maximum opening, sterilization success).
Objective measurements obtained through laboratory testing (e.g., spectral analysis for material, physical force measurements, microbial growth assays).

8. The sample size for the training set:

Not applicable. This device is a mechanical instrument, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, for the same reason as #8.

In summary: The provided FDA 510(k) clearance document details the substantial equivalence of a manual surgical instrument and, therefore, focuses on non-clinical performance, safety (biocompatibility), and sterilization validation against established industry standards. It does not involve the types of clinical studies, AI performance metrics, or ground truth establishment relevant for an AI/SaMD device that the questions are implicitly structured to address.

Summary

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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 (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

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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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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.

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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	ComparisonAnalysis
Product Name	Konig Mogen Clamp	Medicon MogenCircumcision 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 Clampis an instrument used in amedical procedure tocompress the foreskin ofthe penis duringcircumcision of a maleinfant or child.	The Mogen CircumcisionClamp is an instrument usedin a medical procedure tocompress the foreskin of thepenis during circumcision ofa 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, thejaws are designed toseparate to a maximum of2.5 mm. For safe clamping	In the open position, the jawsare designed to separate to amaximum of 2.5 mm. Forsafe clamping the Medicon	Same

	the Konig Mogen Clampis locked with a definedclosing force. For safetyreasons, the lock screw ofthe clamp is fixed with aspot welding point inorder not to become loose.	Mogen Clamp is locked witha defined closing force. Forsafety reasons, the lockscrew of the clamp is fixedwith a spot welding point inorder not to become loose.
Materials	Stainless Steel - corrosionresistant	Stainless Steel- corrosionresistant	Same
PerformanceSpecifications	Standards ASTM F 899-09 and ISO 7153-1Standard Specification forStainless Steels forSurgical InstrumentsASTM E322-12 StandardTest Method For AnalysisOf Low-Alloy Steels AndCast Irons By WavelengthDispersive X-RayFluorescenceSpectrometryASTM F1089-10 StandardTest Method for Corrosionof Surgical InstrumentsASTM E18 - 20 StandardTest Methods forRockwell Hardness ofMetallic Materials	Standards ASTM F 899-09and ISO 7153-1 StandardSpecification for StainlessSteels for SurgicalInstrumentsASTM F 1089-10 and ISO13402 StandardSpecifications for resistanceagainst corrosion andautoclaving of SurgicalInstruments.	Different
Prescription vs. OTC	Prescription	Prescription	Same
Contact Durations	Surface DeviceBreached or compromisedsurfaceLimited duration	Surface DeviceBreached or compromisedsurfaceLimited 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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Medline Industries, Inc. Three Lakes Drive
Northfield, IL 60093

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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 CytotoxicityISO 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 TestASTM E322-12 Standard Test Method For Analysis Of Low-Alloy Steels And Cast Irons By Wavelength Dispersive X-Ray Fluorescence SpectrometryASTM F1089-10 Standard Test Method for Corrosion of Surgical InstrumentsASTM 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.

Regulation Number and Section

§ 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.