(266 days)
Not Found
No
The document describes a laser device for skin ablation and pain reduction, with no mention of AI or ML in its description, intended use, or performance studies.
Yes
The device is described as producing "rapid dermal anesthetic effect" and is used "for the ablation of the outer layer of the skin," both of which are therapeutic actions.
No
Explanation: The device description states its purpose is for the ablation of the outer layer of the skin and does not mention any function for diagnosis or detection of a condition.
No
The device description explicitly states it is a "portable, battery powered, single pulse Er: Y AG laser," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for the rapid production of local dermal anesthesia and ablation of the outer layer of the skin. This is a direct treatment applied to the patient's body.
- Device Description: The device is a laser used to remove a layer of skin. This is a physical intervention on the body.
- Anatomical Site: The device is applied to the skin.
- Performance Studies: The studies described involve measuring pain felt by subjects after a needle insertion, which is a clinical outcome on a living person.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform any such analysis of specimens. It is a therapeutic/procedural device applied directly to the patient.
N/A
Intended Use / Indications for Use
The LAD device is indicated for the rapid production of local dermal anesthesia using topical OTC lidocaine 4%.
The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Norwood Abbey Model LAD-01 is a portable, battery powered, single pulse Er: Y AG laser. The radiant energy produced by this laser has a wavelength of 2.94 um, duration of approximately 300 us, and a beam diameter or spot-size of 3 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
skin
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An IRB, IDE approved study was conducted over two centers and involving 320 subjects. Full needle insertion of a 23G 5/8" needle was used as a standard pain stimulus. After needle insertion subjects were asked to rate the pain felt using an accepted pain ever the model; pain scores were tested to rate the pain felt using an accepted pain evaluation model; pain scores were tested and analyzed as per the approved protocol. Results revealed that the model LAD-01 can produce a rapid dermal anaesthetic effect using topical OTC lidocaine 4%. Analysis of clinical observation c ual observations from 318 subjects treatment revealed no and sisted of clinical observations from 318 subjects taken approximately 48 hours after treatment revealed no adverse events over those of the placebo treatment statyols of chinical observations from 318 subjects taken approximately and
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
510(k) Summary of Safety And Effectiveness for Model LAD-01 1
Submitter Information 1.1
| Norwood Abbey Limited. | 63 Wells Road
Chelsea Heights VIC 3196
Australia |
|------------------------|---------------------------------------------------------------------------------|
| Contact Person: | Andrew Ellis |
| Telephone No.: | +61-3-9782 7344 |
| 1.2 Device Name | Laser surgical instrument for general and plastic surgery
and in dermatology |
| Classification Name: | Laser surgical instrument for general and plastic surgery
and in dermatology |
LAD, model LAD-01 Proprietary Name:
Predicate Devices 1.3
Currently marketed Phoresor II Model 900 (K974855) and the LaserLancet LB100 (K980538) were selected as the predicate devices for this submission.
Description of the Device 1.4
The Norwood Abbey Model LAD-01 is a portable, battery powered, single pulse Er: Y AG laser. The radiant energy produced by this laser has a wavelength of 2.94 um, duration of approximately 300 us, and a beam diameter or spot-size of 3 mm at the treatment site. The radiation delivered by the device is sufficient to remove the stratum corneum of skin exposed to the treatment.
I : રે Indications for Use
The LAD device is indicated for the rapid production of local dermal anesthesia using topical OTC lidocaine 4%.
1.6 Safety& Effectiveness
An IRB, IDE approved study was conducted over two centers and involving 320 subjects. Full needle insertion of a 23G 5/8" needle was used as a standard pain stimulus. After needle insertion subjects were asked to rate the pain felt using an accepted pain ever the model; pain scores were tested to rate the pain felt using an accepted pain
evaluation model; pain scores were tested and analyzed as per the approved protocol.
Perc
Results revealed that the model LAD-01 can produce a rapid dermal anaesthetic effect using topical OTC lidocaine 4%.
Analysis of clinical observation c
ual observations from 318 subjects
treatment revealed no
and sisted of clinical observations from 318 subjects taken approximately 48 hours after
treatment revealed no adverse events over those of the placebo treatment statyols of chinical observations from 318 subjects taken approximately and
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a human profile in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2003
Norwood Abbey Limited c/o Mr. Robert T. Handren, Jr. President Handren Associates, Inc. 5818 Princess Caroline Place Leesburg, Florida 34748
Re: K021222
Trade/Device Name: LAD Model LAD-01 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: October 8, 2002 Received: October 10, 2002
Dear Mr. Handren:
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. Iisting 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.
2
Page 2 - Mr. Robert T. Handren, Jr.
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. 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" (21CFR Part 807.97) you may obtain. 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,
Miriam C. Provost
for 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
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Page 1_of 1
510(k) Number (if known): K021222
Device Name:
Indications for Use:
The LAD is indicated for the ablation of the outer layer of the skin prior to the application of OTC topical 4% lidocaine cream, for local dermal anesthesia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021222