(65 days)
The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coaqulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
Hair Removal (650nm filter) Permanent hair reduction (650nm filter) Treatment of vascular lesions (510nm filter) Treatment of benign pigmented lesions (510 nm filter) Mild to Moderate inflammatory acne (450nm filter)
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er: YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy produced within the device is delivered to the tissue in a wavelength of 2940nm. The Intense Pulsed Light wavelengths are 450nm - 1200nm The user activates laser and IPL emission by means of a footswitch.
The provided document is a 510(k) summary for the Apex Er:YAG / IPL System. This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than proving novel effectiveness through new clinical studies. As such, the document explicitly states there is no performance data and no results of a clinical study provided for the Apex Er:YAG / IPL System itself.
Therefore, the following information, typically found in a clinical study report for device acceptance, is not available in the provided document:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
However, based on the provided text, here's what can be stated about the acceptance criteria and the study that "proves" the device meets them within the context of a 510(k) submission:
1. Acceptance Criteria and Device Performance:
For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to legally marketed predicate devices. The "device performance" is shown through a comparison of technological characteristics and intended uses.
- Acceptance Criteria (Implicit for 510(k)): The device must be substantially equivalent to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. This means the new device should not raise new questions of safety or effectiveness.
- Reported Device Performance (as demonstrated for 510(k) equivalence): The document provides a comparison of the Apex Er:YAG / IPL System with its predicate devices.
| Feature | Apex Er:YAG / IPL (IPL component) | Apollo Mini IPL System (Predicate) | Apex Er:YAG / IPL (Er:YAG component) | MLT Erbium:YAG Laser System (Predicate) |
|---|---|---|---|---|
| Light Source | Pulsed Incoherent Light | Pulsed Incoherent Light | N/A (Laser) | N/A (Laser) |
| Max Fluence | Up to 35 J/cm² | Up to 35 J/cm² | 5 J/cm² | 5 J/cm² |
| Wavelength | 450 - 1200 nm | 450 - 1200 nm | 2940 nm | 2940 nm |
| Spot Size | 35 x 15 mm² | 35 x 15 mm² | 1.5mm, 3mm, 6mm, 9mm | 1.5mm, 3mm, 6mm, 9mm |
| Pulse Width | Up to 200 ms | Up to 200 ms | 300 µs | 300 µs |
| Beam Delivery | Light Guide | Light Guide | N/A | N/A |
| Max Power | N/A | N/A | 2.4 W | 2.4 W |
| Repetition Rate | N/A | N/A | Up to 10 pulse per second | Up to 10 pulse per second |
2. Study that proves the device meets the acceptance criteria (Substantial Equivalence):
The "study" in this context is a comparison of technological characteristics and intended uses against legally marketed predicate devices, rather than a de novo clinical trial.
- Type of Study: Predicate device comparison for substantial equivalence.
- Data Provenance: The data is a comparison of technical specifications provided by the manufacturer against the specifications of the identified predicate devices. It is not derived from retrospective or prospective patient data from a specific country.
- Sample Size: Not applicable. This is not a study involving patient or image data. The comparison is feature-by-feature.
3. & 4. Experts and Adjudication:
- Number of Experts/Qualifications: Not applicable. The 510(k) process for this device did not involve expert review or adjudication of patient cases or images to establish a ground truth. The comparison relies on documented technical specifications.
- Adjudication Method: Not applicable.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. The document explicitly states "Results of Clinical Study: None."
6. Standalone (Algorithm Only) Performance:
- Standalone Study Done: No. This device is a physical laser/IPL system, not an algorithm. The document explicitly states "Performance Data: None."
7. Type of Ground Truth:
- Ground Truth Used: Not applicable in the traditional sense of a clinical study. The "ground truth" for a 510(k) is the established performance and safety of the predicate devices. The new device is accepted if it is shown to have similar characteristics and intended uses that do not raise new questions of safety or effectiveness.
8. & 9. Training Set and Ground Truth for Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.
- How Ground Truth for Training Set was Established: Not applicable.
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Attachment 5 510(K) Summary Apex Er:YAG / IPL System
K 110304
APR - 8 2011
This 510(K) Summary of safety and effectiveness for the Apex Er:YAG / IPL System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Sandstone Medical Technologies, LLC |
|---|---|
| Address: | 105 Citation CourtBirmingham, AL 35209 |
| Contact Person: | Mark Rohrer |
|---|---|
| Telephone: | 205-290-8251 - phone |
| Email: | ssmed@bellsouth.net |
Preparation Date:
January 31, 2011
Apex Er:YAG / IPL System
79-GEX, 21 CFR 878-48
Device Trade Name:
Common Name: Classification Name:
Legally Marketed Predicate Device:
Description of the Apex Er:YAG / IPL System:
Intended use of the Apex Er:YAG / IPL System:
MLT Erbium:YAG Laser System (K)032599 Apollo Mini IPL System (K)081219
ER:YAG laser and Intense Pulsed Light
Instrument, Surgical, Powered, laser
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er: YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy produced within the device is delivered to the tissue in a wavelength of 2940nm. The Intense Pulsed Light wavelengths are 450nm - 1200nm The user activates laser and IPL emission by means of a footswitch.
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510 nm filter), Mild to Moderate inflammatory acne (450nm filter)
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Attachment 5 510(K) Summary Apex Er:YAG / IPL System
Performance Data: None
Results of Clinical Study: None
Summary of Technological Characteristics:
| Sandstone MedicalTechnologies LLC ApexEr:YAG / IPL System | Sandstone MedicalTechnologies LLC ApolloMini IPL System | |
|---|---|---|
| Light Source | Pulsed Incoherent Light | Pulsed Incoherent Light |
| Max Fluence | Up to 35J/cm² | Up to 35J/cm² |
| Wavelength | 450 - 1200 nm | 450 - 1200 nm |
| Spot Size | 35 x 15 mm2 | 35 x 15 mm2 |
| Pulse Width | Up to 200ms | Up to 200ms |
| Beam Delivery | Light Guide | Light Guide |
| Stem |
| Sandstone MedicalTechnologies LLC ApexEr:YAG / IPL System | Sandstone MedicalTechnologies LLCEr:YAG Laser | |
|---|---|---|
| Wavelength | 2940nm | 2940nm |
| Max Power | 2.4 W | 2.4 W |
| Max Fluence | 5J/cm2 | 5J/cm2 |
| Pulse Width | 300 $\mu$ s | 300 $\mu$ s |
| Repetition Rate | Up to 10 pulse persecond | Up to 10 pulse persecond |
| Spot Size | 1.5mm, 3mm, 6mm,9mm | 1.5mm, 3mm, 6mm, 9mm |
Conclusion:
The Apex Er:YAG / IPL is substantially equivalent to the MLT Erbium:YAG Laser System (K)032599 and to the Apollo Mini IPL System (K)081219. The Apex Er: YAG / IPL is substantially equivalent in terms of indication for use and technology based on technical characteristics.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its head turned to the right, symbolizing vigilance and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Sandstone Medical Technologies LLC % Mr. Mark Rohrer 105 Citation Court Birmingham, Alabama 35209
APR - 8 2011
Re: K110304
Trade/Device Name: Apex ER:YAG / IPL System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: January 31, 2011
Received: February 03, 2011
Dear Mr. Rohrer:
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
{3}------------------------------------------------
Page 2 - Mr. Mark Rohrer
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/ReportalProblem/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 yours,
Aty B. Rta
for
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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Indications for Use
K Reading 110304 510(k) Number (if known):
Apex Er:YAG / IPL System Device Name:
The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coaqulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
Hair Removal (650nm filter) Permanent hair reduction (650nm filter) Treatment of vascular lesions (510nm filter) Treatment of benign pigmented lesions (510 nm filter) Mild to Moderate inflammatory acne (450nm filter)
Prescription Use xx (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|--|
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number 110304
§ 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.