The Classic and Esteem vacuum systems are intended to artificially produce an erection in males suffering from erectile dysfunction (impotence) in order to facilitate sexual intercourse. A vacuum is applied to the penis, causing it to become erect and rigid as blood is drawn into the corpora cavernosa. A constriction ring is then placed on the base of the penis to restrict venous blood flow out of the penis. The device is intended to be used at home or in a doctor's office or clinic.

Device Description

The silicone Freedom Ring™ was developed as an alternative constriction ring for the ErecAid Classic and Esteem vacuum erection devices. It is similar to the existing polyisoprene Pressure-Point™ Ring (PPR) in that it contains both a urethral notch and dorsal pressure points. It is designed to deliver the same sealing pressure to the penis, thus preventing escape of blood after an erection is achieved. The Freedom Ring makes the vacuum seal against the base of the penis rather than against the groin, thereby reducing the probability of scrotal tissue or pubic hair entrapment.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ErecAid® Classic and Esteem vacuum erection systems with the new Freedom Ring:

The provided document (K020082) describes a modification to an existing device, a vacuum erection system, specifically the introduction of a new constriction ring called the "Freedom Ring." The core of the submission revolves around demonstrating that this new ring does not introduce new safety or efficacy issues compared to the previously accepted "Pressure-Point Ring" (PPR).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Tests)	Reported Device Performance
Physical Properties and Dimensions: The physical properties and dimensions of the new Freedom Ring™ must be comparable to those of the corresponding sizes of the existing Pressure-Point™ Ring (PPR).	Met: "Physical properties and dimensions of the new Freedom Ring were compared to those of the corresponding sizes of Pressure-Point Ring." (Implies comparability, as it's not stated that they fail to be comparable.)
Pressure Exerted on the Penis: The pressure exerted on the penis by each Freedom Ring must be comparable to that of the corresponding size PPR.	Met: "The pressure exerted on the penis by each Freedom Ring was verified to be comparable to that of the corresponding size PPR."
Initial Vacuum Seal: The Classic and Esteem systems, when used with the Freedom Ring, must continue to meet documented product specifications regarding initial vacuum seal.	Met: "bench testing was conducted to demonstrate that the Classic and Esteem systems continued to meet documented product specifications regarding initial vacuum seal..." (Implies compliance with existing specifications, which likely serve as the acceptance criteria for vacuum seal performance).
Maximum Vacuum Pressure: The Classic and Esteem systems, when used with the Freedom Ring, must continue to meet documented product specifications regarding maximum vacuum pressure.	Met: "...continued to meet documented product specifications regarding... maximum vacuum pressure..." (Implies compliance with existing specifications, which likely serve as the acceptance criteria for maximum vacuum pressure).
Leak Rate: The Classic and Esteem systems, when used with the Freedom Ring, must continue to meet documented product specifications regarding leak rate.	Met: "...continued to meet documented product specifications regarding... and leak rate." (Implies compliance with existing specifications, which likely serve as the acceptance criteria for leak rate).
Clinical Equivalence (Implicit): The new Freedom Ring™ must introduce no new issues of safety or efficacy compared to the predicate device.	Met (Claimed by Manufacturer): "Timm Medical Technologies, Inc. believes that the new Freedom constriction ring introduces no new issues of safety or efficacy with respect to the ErecAid Classic and Esteem vacuum erection systems." (This is a summary conclusion based on the bench testing and the design's intent to improve comfort without affecting the core function.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "bench tests" of the Freedom Ring and the vacuum systems. Given the nature of physical property and pressure measurements, it likely involved a sample of manufactured rings and representative vacuum devices.
Data Provenance: The data originates from bench testing conducted by Timm Medical Technologies, Inc. This is a prospective evaluation of the newly designed Freedom Ring. The country of origin is not explicitly stated but can be inferred as the USA, where the manufacturer is located (Eden Prairie, MN).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. For bench testing of physical properties and mechanical performance, "ground truth" is established by measurement against predefined engineering specifications and comparisons to known performance characteristics of the predicate device (PPR). This typically involves engineers, quality control personnel, and technicians rather than medical experts for establishing ground truth for device performance in this context. While the design was for patient comfort, the testing was against objective benchmarks.
Qualifications of Experts: Not explicitly stated, as no "experts" in the medical sense were used to establish ground truth for this type of testing. The work would have been performed by qualified technical staff.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based evaluations where there is subjective interpretation or diagnostic uncertainty requiring consensus among human readers. For the bench testing described, the measurements are objective, and the results are compared directly to engineering specifications or the predicate device's measured performance. Discrepancies would be resolved through re-testing or analysis of measurement methodologies rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was required to demonstrate safety or effectiveness of the new Freedom constriction ring when used with either the ErecAid Classic or Esteem vacuum erection system."
Effect Size: Not applicable. Since no MRMC study was conducted, there is no reported effect size regarding human readers' improvement with or without AI assistance. (It's important to note this device is not an AI-based diagnostic tool, so such a study would not be relevant in this context anyway.)

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance testing is not relevant or performed.

7. The Type of Ground Truth Used

The ground truth for the bench testing was based on objective engineering and manufacturing specifications for the vacuum devices themselves (initial vacuum seal, maximum vacuum pressure, leak rate) and comparative physical/mechanical properties against the predicate "Pressure-Point Ring" (PPR) for the new Freedom Ring (dimensions, physical properties, and pressure exerted on the penis).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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K020082
Page 1 of 2

FEB 0 5 2002

510(k) SUMMARY

January 04, 2002 Preparation Date:

1.0 Company Information

Manufacturer:	Timm Medical Technologies, Inc.6585 City West ParkwayEden Prairie, MN 55344
---------------	-------------------------------------------------------------------------------------

Contact:

Mr. Chris Hadland 952-562-3972 tel 952-947-9411 fax
No sterilization is performed at this facility.

2.0 Device Modified

Trade Name:	ErecAid® Classic System
	ErecAid® Esteem® Manual System
	ErecAid® Esteem® Battery System
Common Name:	Vacuum Erection Device
Classification:	External Penile Rigidity Device
	Not classified

3.0 Intended Use

Device Modifications 4.0

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K020082
Page 2 of 2

When using the Pressure-Point Ring, it must be stretched over the proximal end of the cylinder. For Esteem users, the optional Easy Action ring loader cone is offered for this purpose. Classic users must accomplish this task manually. Once an erection is achieved, the lubricated ring is slipped off the cylinder onto the base of the penis. This transferal often results in an uncomfortable "snapping" effect on the penis.

The Freedom Ring eliminates this discomfort as there is no transferal process. The patient puts the ring on the cylinder, places the lubricated penis in the ring opening, and begins the pumping action. The head of the penis is drawn into the ring as the vacuum is created. The Easy Action ring loader cannot be used with the new Freedom Ring.

5.0 Performance Tests

Continued safety and efficacy of the ErecAid Classic and Esteem vacuum erection systems, while using the new Freedom constriction ring, were demonstrated through bench tests. Physical properties and dimensions of the new Freedom Ring were compared to those of the corresponding sizes of Pressure-Point Ring. The pressure exerted on the penis by each Freedom Ring was verified to be comparable to that of the corresponding size PPR.

In addition, bench testing was conducted to demonstrate that the Classic and Esteem systems continued to meet documented product specifications regarding initial vacuum seal, and maximum vacuum pressure and leak rate.

6.0 Clinical Studies

No clinical study was required to demonstrate safety or effectiveness of the new Freedom constriction ring when used with either the ErecAid Classic or Esteem vacuum erection system.

7.0 Conclusion

Timm Medical Technologies, Inc. believes that the new Freedom constriction ring introduces no new issues of safety or efficacy with respect to the ErecAid Classic and Esteem vacuum erection systems. It was designed to provide increased patient comfort and ease of use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes forming its body and wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2002

Mr. Chris Hadland VP, Quality and Regulatory Affairs Timm Medical Technologies, Inc. 6585 City West Parkway EDEN PRAIRIE MN 55344

Re: K020082 Trade/Device Name: ErecAid® Classic System ErecAid® Esteem® Manual System ErecAid® Esteem® Battery System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LKY Dated: January 7, 2002 Received: January 10, 2002

Dear Mr. Hadland:

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. 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.

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy Cbrogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

K020082

Page | of |

Device Name:

ErecAid® Classic System ErecAid® Esteem® Manual System ErecAid® Esteem® Battery System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Vorint a. Seaman

Regulation Number and Section

§ 876.5020 External penile rigidity devices.

(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.