(16 days)
No
The description focuses on the physical components and function of a laser beam delivery system, with no mention of AI or ML technologies.
Yes.
The device is used for incision, excision, ablation, or photocoagulation of soft tissue, which are therapeutic medical procedures.
No
The device is described as a component of a surgical laser system used for incision, excision, ablation, or photocoagulation of soft tissue. These are therapeutic, not diagnostic, actions.
No
The device description explicitly states it consists of physical components: a flexible hollow lightpipe (fiber), handpieces, and various tips. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "communicate the laser beam of a CO, surgical laser to the target site for the incision, excision, ablation, or photocoagualtion of soft tissue." This describes a surgical tool used directly on the patient's body for treatment.
- Device Description: The device is described as a "family of detachable devices that comprise the distal portion of a beam delivery system to be used with a CO, surgical laser." This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a tool for performing surgical procedures.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the product(s) is to communicate the laser beam of a CO, surgical laser to the target site for the incision, excision, ablation, or photocoagualtion of soft tissue. Representative examples of clinical applications include:
Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma: ablation of vaginal and vulvar intraepithelial neoplasia; herpes 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 carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis
Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery--hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction 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, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps
Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete mattixectomy; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment
Orthopedic -- menisectorny, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal
No new indications for use are sought beyond those associated with the predicate devices.
Product codes
GEX, EWG, HHR, NVK
Device Description
This is a family of detachable devices that comprise the distal portion of a beam delivery system to be used with a CO, surgical laser such as that described in K96075. Specifically, the devices consist of a flexible hollow lightpipe (fiber), handpieces that connect to the fiber, and various tips that connect to the handpieces. The tips are short, rigid hollow alumina lightpipes producing a variety of spot sizes. The user may "mix and match" handpieces and tips to suit the clinical task at hand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical, vulvar, perineal, vaginal, urethral, skin, gingiva, frenum, hemorrhoids, pilodidal cyst, decubitus ulcers, stasis ulcers, breast, endometriosis, adhesions, lymphangioma, turbinate, subglottic, vocal cord, plantar, fungal nail, menisc, chondromalacia, synovectomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory bench testing confirms that the spot sizes produced by the Aesculight tips are identical to the predicate tips, that the Aesculight tips have similar transmission efficiencies as the predicate tips and have power-handling capabilities that equal or exceed those of the predicate tips.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
SURGICAL LASERS
1-866-697-7548 425-483-8905 Fax 425-483-6015
JUN 2 5 2008 KO81612
510(k) Summary
SURICAL
Date prepared: June 2, 2008
Submitter's name, address, telephone, fax, and contact person;
Aesculight LLC 16928 Woodinville-Redmond Rd N.E., Suite B104 Woodinville, WA 98072 (425)483-8905 telephone (425)483-6015 fax Paul Diaz, Vice President of Engineering
Product trade name: Aesculight family of fibers, handpieces, and tips for CQ surgical lasers
Product common name: Laser flexible fibers, handpieces, and tips
Classification names: General and Plastic Surgery Devices, 21 CFR, 878.4810, product code GEX; ENT Microsurgical CO2 Laser, 21 CFR874.4500, product code EWG; Gynecologic Surgical Laser, 21 CFR 884.4550, product code HHR; Soft Tissue Dental Laser, 21 CFR 878.4810, product code NVK
Legally marketed predicate device: Modified LX-20 Laser System fibers, handpieces, and tips, as described in 510(k) no. K960475
Product description
This is a family of detachable devices that comprise the distal portion of a beam delivery system to be used with a CO, surgical laser such as that described in K96075. Specifically, the devices consist of a flexible hollow lightpipe (fiber), handpieces that connect to the fiber, and various tips that connect to the handpieces. The tips are short, rigid hollow alumina lightpipes producing a variety of spot sizes. The user may "mix and match" handpieces and tips to suit the clinical task at hand.
Intended vse
The intended use of the product(s) is to communicate the laser beam of a CO, surgical laser to the target site for the incision, excision, ablation, or photocoagualtion of soft tissue. Representative examples of clinical applications include:
Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma: ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts
1
Dermatology--port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis
Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery--hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction 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, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps
Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete mattixectomy; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment
Orthopedic -- menisectorny, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal
No new indications for use are sought beyond those associated with the predicate devices.
Technological characterization
When used with a CO, laser, the effect on tissue of the laser beam, as produced by the Aesculight family of products, is identical to that of the predicate products. The Aesculight tips produce the same range of spot sizes as the predicate tips. Cosmetically, dimensionally, and ergonomically, the Aesculight products are very similar to the predicates, and use the same optical principles to conduct the laser light from the base unit to the target site. There are, in some cases however, some differences in construction. The predicate fiber is based upon an optically-coated (for enhanced reflectivity) molybdenum ribbon formed into a long skinny tube (with the optical coating on the inside surface), whereas the Aesculight fiber is based upon internally-coated flexible seamless tubing, This tubing, with no seams or gaps in the optical coating, exhibits somewhat better transmission efficiency than the predicate fiber. While some of the Aesculight tips are identical in construction to the predicate tips, some are not. To produce the smaller spot sizes, the predicate tips use a cone of coated molybdenum ribbon to concentrate the beam, whereas the Aesculight tips are monolithic alumina with a conical lumen. The alumina tips are capable of sustaining higher power throughputs than the predicate foil tips. These differences in construction do not introduce any new safety or performance concerns.
2
The Aesculight handpieces, for the most part, exhibit only minor cosmetic differences to the predicate handpieces. In one case (the backstop handpiece), the Aesculight handpiece is a shorter version of the predicate, and in other cases, Aesculight produces more handpiece models with integral or add-on smoke evacuation capabilities, but these differences merely affect the convenience of use of the handpieces, and have no effect on the laser beam-tissue interaction.
Conclusion
The Aesculight fiber, although differing somewhat in construction, has very similar physical and optical characteristics as the predicate fiber. Both are flexible, optically multi-mode, hollow lightpipes, and both have the same lumen size and length, with the Aesculight version exhibiting superior transmission efficiency. In some cases, the Aesculight handpieces are almost identical to the predicate handpieces; in other cases, the Aesculight handpieces are simple mechanical modifications of the predicate handpieces with the object of providing more convenience for the user. The Aesculight tips are, in some cases, exactly identical to the predicate tips; in other cases, the construction (but not the internal geometry) differs from the predicates, and laboratory bench testing confirms that the spot sizes produced by the Aesculight tips are identical to the predicate tips, that the Aesculight tips have similar transmission efficiencies as the predicate tips and have power-handling capabilities that equal or exceed those of the predicate tips. From a clinical efficacy standpoint, a user could not distinguish a difference between the predicate products and the Aesculight products, nor do the Aesculight products raise any new safety issues.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2008
Aesculight, LLC % Mr. Paul Diaz Vice President of Engineering 16928 Woodinville-Redmond Road Northeast, Suite B104 Woodinville, Washington 98072
K081612 Re:
Trade/Device Name: The Aesculight family of flexible fibers, handpieces,
and 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: June 5, 2008 Received: June 9, 2008
Dear Mr. Diaz:
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. Paul Diaz
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 Postmarket 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 M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Device name: The Aesculight family of flexible fibers, handpieces, and tips for CO, surgical lasers
Indications for use: Representative examples are listed below.
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 carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis
Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors
General Surgery--hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction 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
Qtorhinolaryngology--lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps
Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete matrixectorny; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment
Orthopedic-menisectomy, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal
| Prescription Use | Yes | AND/OR | Over-The-Counter Use | No |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
Concurrence of CDRH, Office of Division Sign-Off (ODE)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 11081612 |
|---|---|
| --------------- | ---------- |