(136 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the light-based technology and its intended uses.
Yes
The device is described as a "light-based medical device designed for treatment of vascular lesions (fascial and leg) and benign pigmented lesions," indicating its use in treating medical conditions.
No
The provided text states that the SpectraPulse system is "indicated for photocoagulation" and "treatment," which describes therapeutic actions rather than diagnostic ones. There is no mention of the device being used to identify, analyze, or interpret medical conditions.
No
The device description explicitly states it is a "light-based medical device," indicating it includes hardware components for generating and delivering light, not just software.
Based on the provided information, the SpectraPulse system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SpectraPulse Function: The SpectraPulse system is described as a light-based medical device used for photocoagulation and photothermolysis of lesions and blood vessels. This is a therapeutic procedure performed directly on the patient's skin, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states treatment of dermatological conditions, not diagnostic testing.
Therefore, the SpectraPulse system falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SpectraPulse system is indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (facial and leg veins), benign pigmented lesions in skin types I-IV according to the Fitzpatrick scale.
The Spectrapulse® pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale.
Product codes
GEX
Device Description
The SpectraPulse system is a light-based medical device designed for treatment of vascular lesions (fascial and leg) and benign pigmented lesions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows a logo with a circular design at the top and text at the bottom. The circular design features an abstract shape, possibly representing a globe or a stylized figure. The text at the bottom appears to be the name of an organization or company, but the letters are not clear enough to read. The overall impression is that of a formal or official emblem.
PRIMARY TECHNOLOGY, LLC 813 S. Westshore Blvd.
Tampa, FL 33609 TEL: 813-288-0260 FAX: 813-288-0614
022609 1/2
DEC 2 0 2002 REVISED - 11/04/02 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness for the SpectraPulse® pulsed light device by Primary Technology is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Primary Technology, LLC |
|---|---|
| Address: | 813 S. Westshore Blvd. |
| Tampa, FL 33609 | |
| Contact Person: | Stephen Almeida |
| Email: | salmeida@spectrapulse.com |
| Telephone: | TEL: |
| 813-288-0260 | |
| FAX: | |
| 813-288-0614 | |
| Preparation Date: | August 5, 2002 |
| Device Trade Name: | SpectraPulse® |
| Common Name: | Pulsed Light Device |
| Classification Name: | Light based surgical instrument for use in General |
| and Plastic surgery and in Dermatology | |
| 21 CFR 878.48 | |
| Panel: 79 | |
| Legally marketed predicate Device: | Palomar Medical Technologies, Inc. |
| EsteLux TM | |
| K020453 | |
| System Description: | The SpectraPulse system is a light-based |
| medical device designed for treatment of | |
| vascular lesions (fascial and leg) and benign | |
| pigmented lesions. | |
| Intended use: | The SpectraPulse system is indicated for |
| photocoagulation of dermatological vascular | |
| lesions, photothermolysis of blood vessels | |
| (facial and leg veins), benign pigmented |
1
KOJ2609 2/2
lesions in skin types I-IV according to the Fitzpatrick scale.
The differences in specifications of the Spectrapulse® and the predicate device do not result in different performance or raise new questions of safety or efficacy.
Based on the foregoing, the SpectraPulse system is substantially equivalent to the legally-marketed predicate device.
Performance Data:
Conclusion:
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2002
Mr. Stephen Almeida President Primary Technology, LLC 813 S. Westshore Boulevard Tampa, Florida 33609
Re: K022607
Trade/Device Name: SPECTRAPULSE® 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 6, 2002 Received: November 7, 2002
Dear Mr. Almeida:
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 (OS) 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.
3
Page 2 - Mr. Stephen Almeida
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). 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
Colia 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
REVISED - 11/4/02 INDICATIONS FOR USE STATEMENT
510(k) Number: K022609
SPECTRAPULSE® DEVICE NAME:
INDICATIONS FOR USE:
The Spectrapulse® pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale.
(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
Prescription use (per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________