(245 days)
Not Found
No
The summary describes a laser device for dermatological procedures and does not mention any AI or ML capabilities.
Yes
The device is intended for dermatological procedures requiring the coagulation of soft tissue, which is a therapeutic action.
No
The device description states its intended use is for "dermatological procedures requiring the coagulation of soft tissue" and to "provide laser energy...for use in a variety of dermatology and general surgery procedures," which are therapeutic applications, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a main body, tablet PC, foot switch, interlock switch, and key switch, and describes the device as providing laser energy.
Based on the provided information, the MiDi-SRS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring the coagulation of soft tissue." This describes a therapeutic or surgical procedure performed directly on a patient's body (in vivo).
- Device Description: The device delivers laser energy to the skin. This is a physical intervention, not a test performed on a sample taken from the body (in vitro).
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MiDi-SRS device's function is to directly treat tissue, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
MiDi-SRS is intended for use in dermatological procedures requiring the coagulation of soft tissue.
Product codes
ONG, GEX
Device Description
MiDi-SRS is designed to provide laser energy (1550nm) for use in a variety of dermatology and general surgery procedures. The product consists of main body, a tablet PC, a foot switch, an interlock switch and a key switch. The device fires a 1550nm Er-glass Fiber laser beam which is then split into a number of microscopic beams, producing tiny dot, or pixel-like treatment zones within the selected target area of the skin, leaving the other zones within it perfectly intact.
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
Bench tests were performed according to EN 60601-2-22, 60601-1 and 60601-1-2 to evaluate its safety and EMC. All the test results met pre-set criteria and support substantial equivalence to the predicate devices.
In vivo animal testing using porcine models was also conducted to obtain histological data of values for depth and zone of ablation and thermal damage immediately post treatment; 3-5 days post treatment; and 10-14 days post treatment. The test results are as below and supports that the subject device would perform as well as the predicate device.
Microscopic treatment zones (MTZs)
Measurement value (µm)
Measured width (S.D.), Measured depth (S.D.), Thermal zone: lateral, Thermal zone: depth
G1 0:
10mJ: 17, 17, 151, 205
20mJ: 33, 34, 226, 290
30mJ: 29, 36, 277, 325
G2 3:
10mJ: 17, 64, 19, 57
20mJ: 13, 16, 42, 132
30mJ: 3, 10, 32, 104
G3 10:
10mJ: 0, 0, 0, 0
20mJ: 0, 0, 0, 0
30mJ: 0, 0, 0, 0
G4 15:
10mJ: 0, 0, 0, 0
20mJ: 0, 0, 0, 0
30mJ: 0, 0, 0, 0
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
SRMC Company, LTD % Ms. Priscilla Chung LK Consulting Group USA Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831
Re: K141046 Trade/Device Name: MiDi-SRS 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: ONG and GEX Dated: November 26, 2014 Received: December 2, 2014
Dear Ms. Chung:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141046
Device Name MiDi-SRS
Indications for Use (Describe)
MiDi-SRS is intended for use in dermatological procedures requiring the coagulation of soft tissue.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K141046)
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
1. Applicant / Submitter:
SRMC CO., LTD 7F, 1130, 2 Sunhwan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,361-825, Republic of KOREA
Tel: +82-43-255-9595 Fax: +82-43-255-5551
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110. Fullerton, CA 92831 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | MiDi-SRS |
|---|---|
| Common Name: | Laser Surgical Unit |
| Classification Name: | Powered Laser Surgical Instrument |
| Classification: | Class II, 21 CFR 878.4810 |
| Classification Product Code: | ONG |
Predicate Device: 4.
SellaS by Dinona Company, Ltd. (K080382)
5. Device Description:
MiDi-SRS is designed to provide laser energy (1550nm) for use in a variety of dermatology and general surgery procedures. The product consists of main body, a tablet PC, a foot switch, an interlock switch and a key switch. The device fires a 1550nm Er- glass Fiber laser beam which is
4
then split into a number of microscopic beams, producing tiny dot, or pixel-like treatment zones within the selected target area of the skin, leaving the other zones within it perfectly intact.
Intended Use: 6.
MiDi-SRS is intended for use in dermatological procedures requiring the coagulation of soft tissue.
7. Performance Data(Non-Clinical):
Bench tests were performed according to EN 60601-2-22, 60601-1 and 60601-1-2 to evaluate its safety and EMC. All the test results met pre-set criteria and support substantial equivalence to the predicate devices.
In vivo animal testing using porcine models was also conducted to obtain histological data of values for depth and zone of ablation and thermal damage immediately post treatment; 3-5 days post treatment; and 10-14 days post treatment. The test results are as below and supports that the subject device would perform as well as the predicate device.
| Group /
Excision
| days | Microscopic treatment zones (MTZs) | ||||
|---|---|---|---|---|---|
| Measurement value (µm) | |||||
| Measured | |||||
| width | |||||
| (S.D.) | Measured | ||||
| depth | |||||
| (S.D.) | Thermal | ||||
| zone: lateral | Thermal | ||||
| zone: depth | |||||
| G1 | |||||
| 0 | 10mJ | 17 | 17 | 151 | 205 |
| 20mJ | 33 | 34 | 226 | 290 | |
| 30mJ | 29 | 36 | 277 | 325 | |
| G2 | |||||
| 3 | 10mJ | 17 | 64 | 19 | 57 |
| 20mJ | 13 | 16 | 42 | 132 | |
| 30mJ | 3 | 10 | 32 | 104 | |
| G3 | |||||
| 10 | 10mJ | 0 | 0 | 0 | 0 |
| 20mJ | 0 | 0 | 0 | 0 | |
| 30mJ | 0 | 0 | 0 | 0 | |
| G4 | |||||
| 15 | 10mJ | 0 | 0 | 0 | 0 |
| 20mJ | 0 | 0 | 0 | 0 | |
| 30mJ | 0 | 0 | 0 | 0 |
8. Substantial Equivalence
The MiDi-SRS is substantially equivalent to the predicate device in terms of indication for use and technology based on technical characteristics. The two devices are similar in the following
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characteristics: intended use, spot size, wave length, aiming beam, power output, energy range, output mode, laser type, and beam mode. The major difference is in the user interface, however, the SW validation report provided in the submission supports that the touch screen tablet SW of the Midi-SRS is substantially equivalent to the predicate device in effectiveness.
9. Conclusion:
Based on the substantial equivalence discussion and testing results, SRMC CO., LTD concludes that the MiDi-SRS is substantially equivalent to the predicate devices in safety and effectiveness.