DUAL YELLOW LASER, MODEL D10B by NORSELD PTY., LTD.

The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.

AI/ML Overview

The provided text describes a 510(k) submission for the Norseld Dual Yellow D10B Laser. However, it does not contain a study or detailed performance data to establish acceptance criteria or prove that the device meets them, beyond stating that it has the "same specifications and indications for use" as a previously cleared predicate device.

Here's an analysis based on the provided text, highlighting what is present and what is missing in relation to your request:

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

Acceptance Criteria: Not explicitly stated in the document. For laser devices, acceptance criteria would typically include parameters like wavelength, power output, spot size, pulse duration, energy density, safety features, and clinical efficacy for specific indications (e.g., clearance rates for vascular/pigmented lesions, complication rates).
Reported Device Performance: The document only states: "The Dual Yellow D10B Laser has the same specifications and indications for use as the YellowStar Laser (K013940) which is also manufactured by Norseld, Pty., Ltd." This implies that its performance is considered equivalent to the predicate device, but no specific performance metrics or clinical trial results are presented for the Dual Yellow D10B Laser itself.

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

The document does not report on any specific test set or clinical study conducted for the Dual Yellow D10B Laser to demonstrate its performance. It relies on the substantial equivalence to the predicate device. Therefore, there is no information on sample size, data provenance, or study design.

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, as no new test set or clinical study specific to the Dual Yellow D10B Laser is described in this document.

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

Not applicable, as no new test set or clinical study specific to the Dual Yellow D10B Laser is described in this document.

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 device is a laser surgical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a hardware device (laser), not an algorithm.

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

Not applicable, as no new clinical study specific to the Dual Yellow D10B Laser is described. For a laser device cleared via substantial equivalence, the "ground truth" implicitly lies within the established safety and efficacy of the predicate device for its intended uses.

8. The sample size for the training set

Not applicable, as no training set for an algorithm is relevant here.

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

Not applicable.

Summary of what is actually present in the document regarding "acceptance criteria" and "study":

The document is a 510(k) summary for the Norseld Dual Yellow D10B Laser. For devices submitted through the 510(k) pathway, the primary "acceptance criterion" is often substantial equivalence to a previously cleared predicate device.

Acceptance Criteria (Implicit): That the Dual Yellow D10B Laser has the "same specifications and indications for use" as the predicate YellowStar Laser (K013940).
Study That Proves the Device Meets Acceptance Criteria: The "study" here is the assertion, accepted by the FDA, that the Dual Yellow D10B Laser is substantially equivalent to the YellowStar Laser. The document states:
- "The Dual Yellow D10B Laser has the same specifications and indications for use as the YellowStar Laser (K013940) which is also manufactured by Norseld, Pty., Ltd."
- "Based on the information in the notification Norseld Pty., Ltd. believes that Dual Yellow D10B Laser is substantially equivalent to (i.e., the same as) the YellowStar Laser System."

This means the manufacturer did not conduct a new clinical trial for the Dual Yellow D10B Laser but rather demonstrated that its design, technology, and intended use are sufficiently similar to a device already on the market (the predicate device) that it does not raise new questions of safety or effectiveness. The FDA's clearance letter confirms their agreement with this assessment of substantial equivalence.

Summary

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

SECTION 8

510(k) SUMMARY

K0 23899

This 510(k) summary of safety and effectiveness for Norseld Dual Yellow D10B laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant: Norseld Pty., Ltd.
Address: 9 Claxton St Adelaide South Australia 5000
Manufacturer: Norseld Pty, Ltd. 9 Claxton St Adelaide South Australia 5000
Contact Person: Mr. Peter Davis Managing Director
Telephone: +618 82319000

Preparation Date: November 2002 (of the Summary)

Device Name: Dual Yellow D10B Laser
Common Name: Laser surgical device

Classification: Laser surgical device Class II medical device 21 CFR 878.4810

Product Code: GEX Panel: 79

Predicate devices: YellowStar Laser System

Device description: The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.

Indications: The Dual Yellow Laser is intended for treatment of vascular and pigmented lesions.

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

The Dual Yellow Laser is a restricted device and is labeled:

"CAUTION: Federal (US) law restricts this device to sale to or use by licensed professionals."

Performance Data: The Dual Yellow D10B Laser has the same specifications and indications for use as the YellowStar Laser (K013940) which is also manufactured by Norseld, Pty., Ltd.
CONCLUSION: Based on the information in the notification Norseld Pty., Ltd. believes that Dual Yellow D10B Laser is substantially equivalent to (i.e., the same as) the YellowStar Laser System.

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of what appears to be an abstract human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Mr. Roger Barnes Regulatory Consultant Norseld Pty., Ltd. 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K023899 Trade Name: Dual Yellow D10BLaser 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: GEX Dated: November 20, 2002 Received: November 22, 2002

Dear Mr. Barnes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.

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

Page 2 - Mr. Roger Barnes

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 (301) 594-4659. 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,

Muriam C. Provost

(or Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SECTION 6 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K023899
---------------------------	---------

Device Name: Norseld Pty., Ltd. Dual Yellow D10B Laser

Indications for Use Statement:

The Dual Yellow Laser is intended for the treatment of vascular and pigmented lesions.

The Dual Yellow Laser is also labeled as a restricted device:

"CAUTION: Federal (US) law restricts this device to sale to or use by licensed professionals."

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use _X (Per 21 CFR 801.109) OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023899

012

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.