The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connection tubing and belt. The device is applied on the patient with the dome over the femoral artery or vein and the belt around the patient. A sterile wound dressing is to be placed between the device and the patient making the device a "non-patient contacting device". The user controls the inflation of the dome by increasing or decreasing the pressure with a connected, manual pump (not provided). The dome applies a mechanical pressure over the spot where there is bleeding, while the arch and belt absorb and evenly distribute the opposite force from the dome. Only the femoral compression device is the subject of this submission; the integrated pump with a manometer is not included in the scope of this submission.

AI/ML Overview

While the provided text describes the regulatory submission for a reprocessed femoral compression device (K120204), it does not include detailed information about acceptance criteria or specific study data to prove the device meets those criteria in the typical format of a clinical or performance study report.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of conducting new effectiveness studies to define and meet specific performance acceptance criteria for an entirely novel device, the manufacturer (SterilMed, Inc.) primarily relies on established performance characteristics of already-approved predicate devices.

Therefore, I cannot populate all sections of your request as if this were a clinical study. However, I can extract the relevant information from the provided document regarding the types of testing performed and the overall conclusion.

Here's how I'll address your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Since specific quantitative acceptance criteria or detailed device performance metrics are not explicitly stated in this 510(k) summary, I will infer the "acceptance criteria" from the types of tests performed and the "reported device performance" from the summary of test conclusions.

Acceptance Criteria (Implied from Test Type)	Reported Device Performance
Cleaning Validation: Reprocessing effectively removes contaminants.	Cleaning validation performed.
Sterilization Validation (ISO 11135, USP <71>): Device achieves specified sterility assurance level.	Sterilization validation performed.
Biocompatibility Testing (ISO 10993-1): Device materials are safe for biological contact.	Biocompatibility testing performed.
Ethylene Oxide Residual Testing (ISO 10993-7): Residual ethylene oxide levels are within safe limits.	Ethylene oxide residual testing performed.
Packaging Validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096): Packaging integrity maintained during handling and storage.	Packaging validation performed.
Shelf Life Validation (ASTM 1980-07): Device maintains functional and safety characteristics over its intended shelf life.	Shelf life validation performed.
Functional Performance (Simulated Use, Visual Inspection, Fatigue Testing, Function Testing): Device operates as intended and is durable.	Validation of functional performance (bench testing) performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed femoral compression device to perform as intended.
Substantial Equivalence: Device is as safe and effective as the predicate devices.	The reprocessed femoral compression device is substantially equivalent to SterilMed's Femoral Compression Device with secondary substantial equivalence to St. Jude Medical's FemoStop™ Gold Femoral Compression System, based on similarities in functional design (principles of operation), materials, indications for use, and methods of construction.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for individual tests. The document states "Representative samples of reprocessed femoral compression devices were tested." This is common in a 510(k) where the focus is on process validation and demonstrating equivalence, rather than a clinical trial with a specific patient cohort sample size.
Data Provenance: Not specified. This would typically be internal company testing and validation data, likely conducted in the US (Minnesota, where SterilMed is located).
Retrospective/Prospective: The testing described (cleaning, sterilization, functional performance, etc.) would be considered prospective as it involves creating and testing samples specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert assessment or interpretation (like an AI study might entail). The "ground truth" here is compliance with validated engineering and biological safety standards.

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

Not applicable. There is no expert adjudication process described, as the tests are objective laboratory and bench tests against defined standards.

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

No, an MRMC comparative effectiveness study was not done. This document is for a medical device (a reprocessed compression device), not an AI diagnostic tool that would involve human readers.

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

This is not applicable, as it is a physical medical device, not an algorithm.

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

The "ground truth" in this context is based on:

Validated Standards: Compliance with established international and US standards (e.g., ISO 11135, USP <71>, ISO 10993-1, ISO 10993-7, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096, ASTM 1980-07) for cleaning, sterilization, biocompatibility, packaging, and shelf life.
Functional Specifications: Meeting predefined functional specifications through bench testing, visual inspection, simulated use, and fatigue testing.
Predicate Device Performance: The underlying assumption is that the predicate devices (SterilMed Femoral Compression Device K012574 and St. Jude Medical FemoStop™ Gold Femoral Compression System K080206) have already demonstrated safety and effectiveness, and the reprocessed device matches those characteristics.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm; therefore, there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

Summary

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K120204

APR - 3 2012

Image /page/0/Picture/2 description: The image contains two lines of text. The first line says "Medical Device Reprocessing". The second line says "Small Equipment & Instrument Repair".

510(K) PREMARKET NOTIFICATION SUBMISSION 20 JANUARY 2012 For Reprocessed Femoral Compression Devices

II. SUMMARY AND CERTIFICATION

510(k) Summary A.

SterilMed, Inc.

Contact Person:

Submitter:

Jason Skramsted 11400 73td Avenue North Maple Grove, MN 55369 Phone: 763-488-3483 Fax: 763-488-4491

Date Prepared:	20 January 2012
Trade Name:	Reprocessed Femoral Compression Device
Classification Name:	Clamp, Vascular, Reprocessed
Classification Number:	Class II, 21 CFR 870.4450
Product Code:	NMF

PredicateDevices:	The reprocessed femoral compression device is substantially equivalent to the SterilMed Femoral CompressionDevice (K012574) with secondary substantial equivalence to the St. Jude Medical FemoStop™ Gold FemoralCompression System(K080206).
DeviceDescription:	The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connectiontubing and belt. The device is applied on the patient with the dome over the femoral artery or vein and the beltaround the patient. A sterile wound dressing is to be placed between the device and the patient making thedevice a "non-patient contacting device". The user controls the inflation of the dome by increasing ordecreasing the pressure with a connected, manual pump (not provided). The dome applies a mechanical pressureover the spot where there is bleeding, while the arch and belt absorb and evenly distribute the opposite forcefrom the dome. Only the femoral compression device is the subject of this submission; the integrated pump witha manometer is not included in the scope of this submission.
IntendedUse:	The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery orvein after catheterization.
Functionaland SafetyTesting:	Representative samples of reprocessed femoral compression devices were tested to demonstrate appropriatefunctional characteristics. Process validation testing was performed to validate the cleaning and sterilizationprocedures as well as device packaging. In addition, the manufacturing process includes visual and validatedfunctional testing of all products produced.
Summary ofNon-clinicalTestsConducted:	Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packagingvalidation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use,visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed femoralcompression device to perform as intended.
Conclusion:	The reprocessed femoral compression device is substantially equivalent to SterilMed's Femoral CompressionDevice with secondary substantial equivalence to the St. Jude Medical's FemoStop™ Gold FemoralCompression System. This conclusion is based upon the devices' similarities in functional design (principles ofoperation), materials, indications for use and methods of construction.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APR - 3 2012

SterilMed. Inc. c/o Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, MN 55369

Re: K120204

Trade/Device Name: Reprocessed Femoral Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular, Reprocessed Regulatory Class: Class II Product Code: NMF, DXC Dated: January 20, 2012 Received: January 23, 2012

Dear Mr. Skramsted:

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 in microsite
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, include 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

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Page 2 - Mr. Jason Skramsted

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 r Rase be devised alat I bermination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I oderal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of K Fart 607); ideeinig (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overse) (QS) regulation (2) CFR Part 820); and if applicable, the electronic form in the quality systems (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 800) ), please 11 you desire specific ad resolved by Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to map. Power Radiological Health's (CDRH's) Office of Compliance. Also, please the Concertified, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Tou may of amall 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.

M. A. Hillemann

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K120204

Medical Device Reprocessing
Small Equipment & Instrument Repair

510(K) PREMARKET NOTIFICATION SUBMISSION 20 JANUARY 2012 For Reprocessed Femoral Compression Devices

Indications for Use

510(k) Number (if known):

Device Name: Reprocessed Femoral Compression Device

Indications for Use:

The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or vein after catheterization.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Killebrew

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K120204

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).