(25 days)
The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction.
In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions.
The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.
Intense Pulsed Light Source
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) notification for the CyDen iPulse i400 System, seeking pre-market approval from the FDA. It outlines administrative information, device design and use characteristics, and the FDA's substantial equivalence determination letter.
Here's a breakdown of why the requested information cannot be provided from the given text:
- No mention of acceptance criteria: The document does not define any specific performance metrics, thresholds, or criteria that the device needs to meet.
- No description of a study: There is no section detailing a clinical trial, performance study, or any other type of investigation conducted to assess the device's efficacy or safety against pre-defined criteria.
- No data on device performance: Consequently, there are no reported device performance results, sample sizes for test sets, data provenance, expert qualifications, or ground truth methodologies.
- No MRMC or standalone study information: These types of studies are not mentioned.
- No training set information: The document does not discuss any training data used for the device, which would be relevant for an AI/algorithm-based device, but this device is an Intense Pulsed Light Source.
The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for class II medical devices. This typically involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often without requiring extensive new clinical trials if technological characteristics and indications for use are similar. The FDA's letter explicitly states that the determination of substantial equivalence does not mean the FDA has determined the device complies with other requirements of the Act or federal statutes and regulations.
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Ko80406
Image /page/0/Picture/1 description: The image contains the logo "CyDen". The logo consists of a stylized letter "C" on the left, followed by the text "CyDen" in a bold, sans-serif font. The overall impression is a clean and modern design.
MAR 1 0 2008
FDA Center for Devices and Radiological Health Document Mail Center, HFZ-401 9200 Corporate Boulevard Rockville, MD 20850
FDA CDRH DMC
FEB 1 4 2008
Received
8th February 2008
510(k) Notification
The document in intended to provide the necessary information required by the FDA for the pre-market 510(k) approval for the iPulse i400 System
| 510(k) Administration Information | |
|---|---|
| Submitter: | Cyden LimitedTechnium, Kings Road, The DocksSwansea SA1 8PH, Wales, UK |
| Official Contact: | Dr Mike KiernanConsultant |
| Telephone: | UK +44 1792 485682 |
| Fax: | UK +44 1792 485524 |
| Email: | mikekiernan@hotmail.com |
| Submission Type: | SPECIAL 510(k) |
| Device Type: | Intense Pulsed Light Source |
| ClassificationRegulation: | The iPulse System is a Laser SurgicalInstrument for use in General and PlasticSurgery and in Dermatology and therefore isclassified under 21 CFR 878.4810 |
| Class: | Class II |
| Panel: | General and Plastic Surgery |
| Product Code: | GEX - Laser Powered Surgical Instruments(and Accessories) |
| Submission Basis: | Modification to Existing Device |
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In accordance with the guidelines, the principle factors about the design and use of the device are tabulated in Table 1.
| Table 1: Design and Use of the Device | ||
|---|---|---|
| YES | NO | |
| Is the device intended for prescription use (21 CFR 801 Subpart D)? | YES | |
| Is the device intened for over-the-counter use (21 CFR 807 Subpart C)? | YES | |
| Does the device contain components derived from a tissue or otherbiological source? | NO | |
| Is the device provided sterile? | NO | |
| Is the device intended for single use? | NO | |
| Is the device a reprocessed single use device? | NO | |
| If yes, does this device type require reprocessed validation data? | N/A | |
| Does the device contain a drug? | NO | |
| Does the device contain a biologic? | NO | |
| Does the device use software? | YES | |
| Does the submission include clinical information? | NO | |
| Is the device implanted? | NO |
Please call me on the above number if you have any queries or comments.
Signature
Dr Mike Kiernan Consultant
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CyDen Limited % Dr. Mike Kiernan Technium, Kings Road The Docks Swansea, SA1 8PH Wales, UK
Re: K080406
Trade/Device Name: IPL iPulse i400 Systems 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: March 3, 2008 Received: March 5, 2008
MAR 1 0 2008
Dear Dr. Kiernan:
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
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Page 2 - Ms. Sharon Rockwell
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 N. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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f 0406
Indications for Use Statement
510(k) Number (if known): Unknown
Device Name: IPL iPulse i400 System
Indications For Use:
The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction.
In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions.
The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
NeR.P.S.h. Sormxn
(Division S Division of General, Restorative, and Neurological Devices
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510(k) Number K080406
§ 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.