(183 days)
Not Found
Not Found
No
The summary describes a laser device with a specific wavelength and physical characteristics. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities. The "Not Found" entries for AI/ML mentions and training/test set descriptions further support this conclusion.
Yes
The device is a surgical laser intended for ablation, incision, vaporization, and coagulation of soft tissue, which are therapeutic actions.
No
The device description clearly states its intended uses are for surgical procedures (ablation, incision, vaporization, coagulation) of soft tissue, not for diagnosing conditions.
No
The device description clearly states it is a Nd:YAG laser with a physical weight and dimensions, requiring electrical power, and activated by a footswitch. These are all characteristics of a hardware device, not software only.
Based on the provided information, the Smart File laser device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for performing surgical procedures on soft tissue within the body (intraoral, general, oral maxillo-facial). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) outside the body to provide information about a person's health.
- Device Description: The description details a surgical laser device, not a device designed for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Smart File laser device is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Smart File is indicated for ablation, incision, excision, coagulation and vaporization of intraoral soft tissue.
The Smart File laser device is to provide the ability to perform intraoral soft tissue, general, and oral maxillo-facial surgery. The device is intended for ablation, incision, vaporization and coagulation of soft tissue using a contact, fiber optic delivery system. The device will be used in the folowing areas: general dentistry, otolaryngology, dermatology and plastic surgery.
Product codes
GEX
Device Description
Smart File is a Nd:YAG laser, having a Nd:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 1,064 nm. Laser activation is by footswitch. Overall weight of the laser is 38 Kg, and the size is 68x23x65 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft tissue
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)
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Millennium PerioLase and Lares Research SunLase 800P
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
OCT - 9 2003
: 上一篇:
K03115 - 1 + 1
1 of 1
510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | April 9, 2003 |
| Device Trade Name: | Smart File, Smart File 6, Smarty A10 |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Millennium PerioLase and Lares Research SunLase 800P |
| Device Description: | Smart File is a Nd:YAG laser, having a Nd:YAG crystal rod as the
lasing medium. It is a laser with a wavelength of 1,064 nm.
Laser activation is by footswitch. Overall weight of the laser is 38 Kg,
and the size is 68x23x65 cm (HxWxD).
Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Smart File is indicated for ablation, incision, excision, coagulation
and vaporization of intraoral soft tissue. |
| Comparison: | The Smart File laser has an equivalent indication for uses, the same
principle of operation, the same wavelength and essentially the same
pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Smart File laser is another safe and effective device for intraoral
soft tissue applications. |
| Additional Information: | none |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
OCT - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K031125 Trade/Device Name: Cynosure Smart File Laser Smart File, SmartFile 6, Smarty A10 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: August 28, 2003 Received: August 29, 2003
Dear Mr. Cho:
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 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. George Cho
This letter will allow you to begin marketing your device as described in your Section 510(k) prematket 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.
Miriam C. Provost
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
3
Page 1 of 1
K03125 510(k) Number (if known):
Device Name: __Cynosure Smart File Laser (Smart File, Smart File 6, Smarty A10)
Indications For Use:
The Smart File laser device is to provide the ability to perform intraoral soft tissue, general, and oral maxillo-facial surgery. The device is intended for ablation, incision, vaporization and coagulation of soft tissue using a contact, fiber optic delivery system. The device will be used in the folowing areas: general dentistry, otolaryngology, dermatology and plastic surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K 031125 510(k) Number -
Prescription Use
OR
Over-The-Counter Use_