The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are non-invasive, portable therapeutic medical laser systems designed to deliver light energy to the target tissue. The red and infrared lamps provide continuous heat therapy at a fixed frequency. The System operates by AC power and is used with 8 up to 12 faser modules, as standard 4 red and 4 infrared modules. The system consists of a Control Unit / Power Supply that houses the electronics and controls the power and varies the frequency of the each laser module. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are equipped with single fibre optics to bring the emitted energy to the tissue. That allows treatment either of small or of expanded pain areas as well as both at the same time.

AI/ML Overview

The provided document (K073352) describes the 510(k) premarket notification for the "weberneedle®basic laser" and "weberneedle®basic "compact edition" laser." It does not contain an acceptance criteria table or a study that proves the device meets specific acceptance criteria in the way typically expected for a diagnostic or AI-powered medical device.

This submission is for an infrared lamp, a therapeutic device that provides topical heating. The FDA determined substantial equivalence to legally marketed predicate devices, meaning it has the same intended uses and similar technical and performance characteristics. The testing described is "functional performance testing and electrical safety testing," rather than a clinical efficacy study with acceptance criteria for device performance against a ground truth.

Here's why the requested information cannot be fully provided based on the input:

Type of Device: The weberneedle®basic laser is a therapeutic device (infrared lamp) for topical heating, not a diagnostic device or an AI-powered system that generates a "performance" metric (like sensitivity, specificity, AUC) against a ground truth.
510(k) Pathway: The 510(k) pathway for medical devices focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy against a specific quantitative acceptance criterion as might be seen for novel devices or high-risk devices.

Therefore, many of the requested fields are not applicable to this type of submission.

However, I can extract the closest information available:

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

The document states that the device is "designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by Federal Food and Drug Administration." It also says "The weberneedle®basic laser and the weberneedle®basic "compact edition" laser perform as intended and do not raise any new safety or efficacy issues."

No specific quantitative acceptance criteria or performance metrics (like temperature ranges, duration of heat, etc.) are provided in this summary. The "performance" is implicitly tied to its ability to function as an infrared lamp and deliver topical heating, and its equivalence to predicate devices for the stated indications.

Acceptance Criteria	Reported Device Performance
Explicit quantitative criteria for therapeutic effect not stated in this document.	Explicit quantitative performance for therapeutic effect not stated in this document.
Functionality as an infrared lamp	Performs as intended, delivers light energy for topical heating.
Electrical Safety	Testing includes electrical safety testing.
Compliance with therapeutic heat performance specifications	Designed to comply by producing a level of tissue temperature reported in literature and accepted by FDA.
Substantial Equivalence to Predicate Devices	Has the same intended uses and similar functional and performance characteristics as predicate devices.

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

The document refers to "functional performance testing and electrical safety testing." It does not describe a clinical study with a "test set" of patients or data in the way an AI/diagnostic device would. Therefore, sample size and data provenance are not applicable or described.

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

Not applicable, as there is no "test set" requiring ground truth establishment by experts for a diagnostic performance evaluation.

4. Adjudication method for the test set

Not applicable.

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, as this is not an AI-assisted diagnostic device.

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

Not applicable, as this is a physical therapeutic device, not an algorithm.

7. The type of ground truth used

Not applicable. For this type of device, "ground truth" would relate to its physical properties (e.g., emitted wavelength, power, temperature achieve d) and safety standards adherence, rather than a diagnostic label. The "ground truth" for substantial equivalence is derived from the characteristics and clearances of the predicate devices.

8. The sample size for the training set

Not applicable, as this device does not use a "training set" in the context of machine learning.

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

Not applicable.

Summary

{0}------------------------------------------------

AUG 11 2008

pq 1 of 3

Waber Medical GmbH Germany weberneedle@basic laser, 510(k) Notification June 1901. 2008

K073352

5. 510(k) PREMARKET NOTIFICATION SUMMARY

(as per 21 CFR Part 807.92)

I. Applicant:

Weber Medical GmbH Sohnreystrasse 6 37697 Lauenförde GERMANY

Tel.: +49 5273 36778 - 0 Fax: +49 5273 36778 - 19 Email: weber@webermedical.com

Pf
Or
Stlu

Key Contact: Dr. med. Dipl. Chem. Michael Weber (Chairman)

II. Device Name

Proprietary Name:

weberneedle@basic laser weberneedle@basic "compact edition" laser Infrared Lamp Class II, Infrared Lamp (21 CFR 890.5500) ILY

Product Code:

Common / Usual Name:

Classification Name:

III. Intended Use of the Device

The weberneedle@basic laser is indicated to provide topical heating for the following:

· temporary increase of local blood circulation.
· temporary relief of minor muscle and joint aches, pains, and stiffness.
· temporary relaxation of muscles.
· temporary relief of muscle spasms.
· temporary relief of minor pain and stiffness associated with arthritis.

IV. Predicate Device

The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. Representative predicate devices to the weberneedle@basic laser and the weberneedle®basic "compact edition" laser include, but are not limited to, the Thor Int. DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662). These

weber medical GmbH · HRB 101161 HOL · Registergericht Holzminden Bankverbindung: Commerzbank Holzminden · BLZ: 272 400 04 · Kontonummer: 58 00 610

{1}------------------------------------------------

pg 2 of 3

Weber Medical GmbH. Germany weberneedle@basic laser, 510(k) Notification Juna 19 2008

K073352

devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification Process.

V. Description of the Device

VI. Summary of the Technical Characteristics of the weberneedle®basic laser as Related to the Referenced Predicate Devices.

The weberneedle@basic laser, the weberneedle@basic "compact edition" laser and the aforementioned predicate devices are infrared lamps as defined in 21CFR 890.5500. These devices utilize infrared and visible red diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint aches, pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The weberneedle@basic laser, the weberneedle@basic "compact edition" laser and the named predicate devices have the same intended uses and similar technical and performance characteristics.

VII. Testing

Testing of the System includes functional performance testing and electrical safety testing.

VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the weberneedle@basic laser and the weberneedle@basic "compact edition" laser has the same intended uses, with similar functional and performance characteristics. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue

Page 7 of 80

{2}------------------------------------------------

pg 3 of 3

Weber Medical GmbH, Germany weberneedle@basic laser, 510(k) Notification June 19", 2008

K073352

36797 Lauenförde

temperature reported in literature and accepted by Federal Food and-Drug Administration.

The weberneedle®basic laser and the weberneedle®basic "compact edition" laser perform as intended and do not raise any new safety or efficacy issues. Submitter: Dr. med. Dipl. Chem. Michael Weber (Chairman & General Manager) Sohnreystrasse 6

weber medical GmbH · HRB 101161 HQL · Registergericht Holzminden
Bankverbindung: Commerzbank Holzminden · BLZ: 272 400 04 · Kontonummer: 58 00 610

Page 8 of 80

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake entwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Weber Medical GmbH % Underwriters Laboratories, Inc. Mr. Jeff D. Rongero 12 Laboratory Drive Research Triangle, North Carolina 27709

AUG 11 2008

Re: K073352 Trade/Device Name: weberneedle®basic laser weberneedle®basic "compact edition" laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: ILY Dated: July 28, 2008 Received: July 29, 2008

Dear Mr. Rongero:

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

{4}------------------------------------------------

Page 2 - Mr. Jeff D. Rongero

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pretmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

pg 1 of 1

Weber Medical GmbH, Germany weberneedle@basic laser, 510(k) Notification June 19", 2008

K073352

4. STATEMENT OF INDICATION FOR USE

510(k) Number (if known)

Pending

Device Name:

weberneedle@basic laser weberneedle@basic "compact edition" laser

Indication for Use:

The weberneedle@basic laser is indicated to provide topical heating for the following:

· temporary increase of local blood circulation.
· temporary relief of minor muscle and joint aches, pains, and stiffness.
· temporary relaxation of muscles.
· temporary relief of muscle spasms.
· temporary relief of minor pain and stiffness associated with arthritis.

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!)

(Divisio Division of General, I Restorative. and Neurological Devices

510(k) Number 1601332

Page 5 of 80

Regulation Number and Section

N/A