Intended use is to communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:

Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.

Dermatology – port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.

Dentistry/Oral Surgery – gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors

General Surgery - hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.

Laparoscopic surgery – vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.

Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.

Podiatry – plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment

Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal

Device Description

These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue when utilized in a mating laser handpiece.

AI/ML Overview

The provided text describes a 510(k) submission for the LightScalpel family of handpiece tips for CO2 surgical lasers. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to a change in the sterilization method.

Here's an analysis of the acceptance criteria and supporting study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Sterilization to 10⁻⁶ SAL (Sterility Assurance Level)	Validation of sterilization parameters required for obtaining 10⁻⁶ SAL utilizing radiation sterilization was provided.
Identical construction and performance to predicate device	The devices are described as "identical to the predicate products, utilizing the same specifications, materials and methods."
No new indications for use sought beyond predicate device	"No new indications for use are sought beyond those associated with the predicate device."

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

Sample size for test set: Not explicitly stated in the provided text. The nonclinical performance data refers to "validation of sterilization parameters," which would involve a specific number of sterilization cycles and tests, but the exact sample size (e.g., number of test units) is not given.
Data Provenance: The nature of the study (sterilization validation) suggests a controlled laboratory setting. The origin (e.g., country) of the tests or where the validation was performed is not mentioned. It is an internal study conducted by the manufacturer to support their 510(k) submission.

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

Not applicable. This submission does not involve clinical data or expert evaluation of device performance in a diagnostic or treatment context that would require expert-established ground truth. The primary focus is on sterilization efficacy.

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

Not applicable. There is no mention of adjudication, as the study is a nonclinical validation of sterilization rather than an assessment of subjective interpretations.

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:

No. An MRMC study was not done. The device is a surgical laser handpiece tip, not an AI-assisted diagnostic or treatment system involving human readers.

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

No. The device is a physical medical instrument, not a software algorithm.

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

The "ground truth" for the sterilization validation would be a predetermined sterility assurance level (SAL), specifically 10⁻⁶ SAL. This is an objective, quantitative standard. The validation demonstrates that the chosen sterilization process consistently achieves this sterility level under defined conditions.

8. The sample size for the training set:

Not applicable. This is a nonclinical validation study for a physical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model.

Summary

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Section 5: 510(k) summary

K121471

Date Prepared: 28 June 2012

JUL 1 0 2012

Submitters name, address, telephone, fax, and contact person:

LightScalpel LLC 16932 Woodinville-Redmond Rd NE Suite 201 Woodinville, WA 98072 425-408-9477 425-487-1157 fax Gerald S. Palecki, General Manager

Product Trade Name: LightScalpel family of handpiece tips for CO2 surgical lasers

Product common names: Accessory laser tips

Classification names: Laser surgical instrument for use in general and plastic surgery and in dermatology, 21CFR 878.4810, product code GEX . Panel: General and plastic surgery devices,

Legally marketed predicate device: Aesculight family of fibers, handpieces, and tips for CO2 surgical lasers. (K081612)

Device description: These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue when utilized in a mating laser handpiece.

Intended use: The intended use is to communicate the laser beam of a CO₂ surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use:

Dermatology - port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis.

Dentistry/Oral Surgery - gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors

General Surgery – hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast

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biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures.

Laparoscopic surgery - vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.

Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.

Podiatry - plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment

Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal

No new indications for use are sought beyond those associated with the predicate device.

Summary technological characteristics and comparison to Predicates: These products are identical to the predicate products, utilizing the same specifications, materials and methods. The only difference between these products and the predicates is the final sterilization method and the attendant packaging and labeling. The sterilization method changes from user steam sterilization with the predicate to pre-sterilized radiation sterilization with the submitted devices. Both sterilization methods demonstrate the ability to sterilize to 10 € SAL.

Nonclinical Performance Data: Data were provided relative to the validation of sterilization parameters required for obtaining 105 SAL utilizing radiation sterilization.

Clinical Performance Data: None

Conclusion: The submitted devices are substantially equivalent to the predicate devices with identical construction and performance with validated sterilization to 100 SAL.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle.

JUL 10 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

LightScapel, LLC % Mr. Gerald S. Palecki General Manager 16932 Wood-Red Road Northeast Suite 201 Woodinville, Washington 98072

Re: K121471

Trade/Device Name: LightScalpel family of handpiece tips for CO2 surgical lasers 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: May 14, 2012 Received: May 18, 2012

Dear Mr. Palecki:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Gerald S. Palecki

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

signature

2 Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510(k) Number (if known):

Device Name: LightScalpel family of handpiece tips for CO2 surgical lasers

Indications for Use:

Dentistry/Oral Surgery – gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors

Laparoscopic surgery – vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy.

Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps.

Podiatry – plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment

Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal

Prescription use	Yes
(Part 21CFR 801 Subpart D)

ANDND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Nelkegl Concurrence of CDRH, Office of device Evaluation (ODE)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121471

LightScalpel LLC 510(k) Submission page 4-1

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.