(176 days)
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200 Control panel type P / K Control unit: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
The provided text is a 510(k) summary for the Ergoline Ergoselect 100 K/P and Ergoselect 200 K/P ergometers. It states that the device is deemed "substantially equivalent" to a predicate device (K851097), which means it has similar intended use and technological characteristics, and therefore does not raise new questions of safety or effectiveness.
Crucially, this type of submission (510(k)) for substantial equivalence typically does not involve a new stand-alone clinical study with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies of the kind you've asked for. Instead, the manufacturer demonstrates that their device is as safe and effective as a legally marketed predicate device.
Therefore, many of your requested points are not applicable to the information contained in this 510(k) summary. I will answer the applicable parts and indicate where information is not present.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission does not present a de novo clinical study with specific acceptance criteria and detailed performance metrics as you typically find for novel devices. Instead, a substantial equivalence determination is made against a predicate device. The "acceptance criteria" here are met by demonstrating that the new device is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate K851097) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Intended Use: Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity. | Intended Use: Identical. "Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity." |
| Technological Characteristics: No technical characteristics existing that would raise new questions regarding safety and effectiveness. | Technological Characteristics: "The implemented technology of the Ergoline Ergometers is identical or similar following the Substantial Equivalence comparison rational. No technical characteristics in terms of similarity/differences are existing that would raise new questions regarding safety and effectiveness." Cardiac monitor meets AAMI/ANSI EC13:1992. |
| Safety and Effectiveness: Demonstrated to be as safe and effective as the predicate device. | Safety and Effectiveness: "it is concluded that the Ergoline Ergometers are safe and effective for their Intended Use and that Substantial Equivalence is verified and justified in comparison to the Predicate Device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k) submission. The submission relies on a comparison to a predicate device, not a new clinical study with a test set of patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for this 510(k) submission. No independent expert review of a new test set was conducted for this substantial equivalence determination.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this 510(k) submission. No test set requiring adjudication was used.
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 for this device (ergometer) or this type of submission (510(k) for substantial equivalence). This device is an ergometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable for this device (ergometer) or this type of submission. This device is an ergometer; it does not involve algorithms for standalone performance measurement in the context of diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device (K851097). The new device is compared against this predicate.
8. The sample size for the training set
- Not applicable for this 510(k) submission. This device is an ergometer, not an AI-driven system that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable for this 510(k) submission. As there is no training set for an AI algorithm here, no ground truth needed to be established in that manner. The "ground truth" for the submission is the regulatory acceptance of the predicate device.
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APR 2 7 2005
Summary of Safety and Effectiveness
1. ) Submission Applicant & Correspondent
| Name: | Ergoline GmbHLindenstr. 572475 Bitz/Germany |
|---|---|
| Phone: | xx49-7431-98949 |
| Fax: | xx49-7431-9894127 |
| Mail: | info@bell-qm.de |
Contact person : Haiko Bell
2.) Device name & Classification panel
Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P Trade name:
Common name:Ergometer
Classification: 890.5360
3.) Substantial Equivalence:
Substantial Equivalence is claimed to the following device
4. ) Description of device
Physiotherapy in redevelopment of muscles for restoration to joints or for use as an adjunct treatment for obesity.
The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements
for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
Material:
PPSU - Polyphenylsulfon - BODY Stainless Steel -- ST37K- yellow zinced- FRAME/SADDLE TUBE/SADDLE GUIDE TUBE Polyol, Isocyanate, Emerald leather - SADDLE
Cardiac monitor ( in compliance with Recognized Consensus standard AAMI/ANSI EC13:1992, Cardiac monitors, heart rate meters, and alarms):
Control head type K offers the possibility of measuring the heart rate via an integrated receiver and a chest belt for the patient. ORS Signals/data are radio transmitted from the chest belt to the control head type K receiver. Identification of the chest belt takes 10 seconds. The current heart rate of the patient is then indicated and updated at the control head. The chest belt is switched on automatically as soon as sufficient contact between the two contact areas is established.
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Summary of Safety and Effectiveness
Exercised Muscles:
- Front of thighs
- Quadriceps
- Backer Thighs (hamstrings)
- Pelvis
- Gluteal muscles
- Calfs
- Gastrocnemius
- Soleus
Exercised Joints:
- Hip extensor
- Hip flexor
- Knee extensor
- Knee flexor
- Ankle plantar flexor
The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200
Control panel type P / K Control unit:
Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
5.) Intended Use & indications:
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
6. } Summary of Technological Characteristics:
The implemented technology of the Ergoline Ergometers is identical or similar following the Substantial Equivalence comparison rational. No technical characteristics in terms of similiarity/differences are existing that would raise new questions regarding safety and effectiveness.
7.) Conclusion:
Based upon the information presented within this Premarket Notification and summarized above, it is concluded that the Ergoline Ergometers are safe and effective for their Intended Use and that Substantial Equivalence is verified and justified in comparison to the Predicate Device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the seal is a stylized image of three human figures in profile, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2006
Ergoline GmbH c/o Mr. Stefan Preiss 510 (K) TPR Program Manager TÜV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K053078
K035076
Trade/Device Name: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring exercise equipment Regulatory Class: II Product Codes: ISD Dated: April 6, 2006 Received: April 12, 2006
Dear Mr Preiss:
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 such 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
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Page 2 - Mr. Stefan Preiss
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): KOSJO 78
Device Name: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P
Indications for Use:
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number Ko53098
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.