(147 days)
Not Found
No
The summary describes a laser lancing device with no mention of AI or ML capabilities, image processing, or data sets for training/testing algorithms.
No
The device is used for obtaining capillary blood samples, which is for diagnostic purposes, not for treating a disease or condition.
No
The device is described as a "laser lancing device indicated for obtaining capillary blood samples," which means it collects samples, but it does not analyze or interpret them for diagnostic purposes.
No
The device description explicitly states it is a "portable, battery-operated laser lancing device" and details its hardware components (pulsed Erbium YAG laser). The performance studies also focus on hardware-related testing (laser safety, electromagnetic compatibility, electrical safety, biocompatibility).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. This typically involves analyzing blood, urine, tissue, etc., to detect diseases, conditions, or monitor health.
- The ORTIV laser lancing device's intended use is to obtain a capillary blood sample. It is a tool for collecting the specimen, not for analyzing it or providing diagnostic information itself.
The device description and intended use clearly state its function is to create a small hole in the skin to access capillary blood. This is a sample collection method, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.
Product codes
GEX
Device Description
ORTIV laser lancet is a portable, battery-operated laser lancing device, and is indicated for obtaining capillary blood samples in both institutional and at-home settings. The laser is a pulsed Erbium YAG (ER: YAG). It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
institutional and at-home settings.
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
Non-clinical tests were performed.
- Basic safety and essential performance of the ORTIV is tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1:2020.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014 +AMD1:2020.
- Safety of laser product is evaluated in accordance with IEC 60825-1: 2014.
- Risk management was recorded by referring to ISO 14971:2007.
- Usability was documented by referring to ISO 62366-1:2020.
- Biocompatibility testing per ISO 10993-1.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
November 1, 2024
Mvitro Co., Ltd. % Do-Hyun Kim CEO BT Solutions, Inc. Unit 904. Eonju-ro 86gil 5. Gangnam-gu Seoul. 06210 Korea, South
Re: K241646
Trade/Device Name: Ortiv (ortiv-bl. Ortiv-wh) 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: October 2, 2024 Received: October 2, 2024
Dear Do-Hyun Kim:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.11.01 13:48:27
-04'00'
for
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
ORTIV (ORTIV-BL, ORTIV-WH)
Indications for Use (Describe)
The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary - K241646
1 General Information
| Applicant/Submitter: | MVITRO Co., Ltd. |
|---|---|
| Address: | 2F Hannam Bldg., 254 UN Village-gil |
| Yongsan-gu, Seoul, 04420 | |
| Republic of Korea | |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86gil 5, |
| Gangnam-gu, Seoul 06210, Korea. | |
| Tel: +82-2-538-9140 | |
| Email: ceo@btsolutions.co.kr | |
| Email: smanager@btsolutions.co.kr | |
| Preparation Date: | May 30, 2024 |
2 Device Name and Code
| Device Trade Name: | ORTIV |
|---|---|
| Model Name: | ORTIV-BL, ORTIV-WH |
| Common Name: | Laser lancet |
| Classification Name: | Powered Laser Surgical Instrument |
| Product Code: | GEX |
| Regulation Number: | 21 CFR 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3 Technical Characteristics in Comparison to Predicate Devices
The ORTIV is substantially equivalent to the following legally marketed predicate device. Table 1: Comparison of the proposed device to the predicate device K172818
| Proposed Device | K172818 | Equivalence | |
|---|---|---|---|
| Company | MVITRO Co., Ltd. | Lameditech Co., Ltd. | - |
| Product name | ORTIV | LMT-3000 | - |
| Product code | GEX | GEX | YES |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | YES |
| Classification | Class II | Class II | YES |
| Intended Use | The ORTIV is a portable, battery-operated laser lancing device | The LMT-3000 is a portable, battery-operated laser lancing device | YES |
| indicated for obtaining capillary | |||
| blood samples in both institutional | |||
| and at-home settings. | indicated for obtaining capillary | ||
| blood samples in both institutional | |||
| and at-home settings. | |||
| Technological characteristics | |||
| Wavelength | 2940 nm | 2940 nm | |
| Laser source | Er:YAG | Er:YAG | |
| Laser class | Class 3R (IEC 60825-1) | Class 4 (IEC 60825-1) | Different |
| Mechanism | |||
| of Action | The laser lancet installed on the | ||
| ORTIV is a pulsed Erbium YAG | |||
| (ER: YAG) laser. It outputs a single | |||
| pulse of laser light with a wavelength | |||
| of 2940 nm, which ablates a small | |||
| hole in the skin to a depth sufficient | |||
| to access capillary blood. | The LMT-3000 Laser Skin Perforator | ||
| is a pulsed erbium doped | |||
| yttriumaluminum- garnet (Er:YAG) | |||
| laser. It outputs a single pulse of laser | |||
| light with a wavelength of 2940 nm, | |||
| which ablates a small hole in the skin | |||
| to a depth sufficient to access | |||
| capillary blood. | YES | ||
| Technology | |||
| Overview | The wavelength of this laser is 2940 | ||
| nm, which matches water's | |||
| absorption peak. Considering that | |||
| water is the major constituent of | |||
| organic tissue, it's possible to explain | |||
| the strong absorption of tissue for this | |||
| wavelength. | |||
| On the other hand, due this strong | |||
| absorption in water, this laser | |||
| exhibits a little penetration depth. | The wavelength of this laser is 2940 | ||
| nm, which matches water's | |||
| absorption peak. Taking into account | |||
| that water is the major constituent of | |||
| organic tissue, it's possible to explain | |||
| the strong absorption of tissue for this | |||
| wavelength. | |||
| On the other hand, due this strong | |||
| absorption in water, this laser | |||
| exhibits a little penetration depth. | YES | ||
| Battery | |||
| Operated | Rechargeable battery (3.7 Vdc) | Rechargeable battery (3.7 Vdc) | YES |
| Laser pulse | |||
| repetition | |||
| rate | Single | Single | YES |
| Anatomical | |||
| location | Fingers | Fingertips | YES |
| Operating | |||
| humidity | 10-90% | Relative humidity 5 to 90%, | |
| noncondensing | Similar | ||
| Operating | |||
| temperature | 10~40°C | Ambient temperature +5 to +40°C | Similar |
| Storage | |||
| temperature | 10 ~ 40°C | Ambient temperature -10 to +60°C | Similar |
| Storage | |||
| humidity | 10-90% | Relative humidity 5 to 90%, | |
| noncondensing | Similar | ||
| Sterile | No | No | YES |
| Material | Polycarbonate | Polycarbonate | YES |
| Single-Use | No | No | YES |
| Laser Power | |||
| range | 150 mJ (±20%) | Unknown | N/A |
| Applied part | |||
| type | BF | BF | YES |
| Intended for | Prescription Use | Prescription Use | YES |
5
ORTIV
510(k) Summary
6
510(k) Summary
4 Device Description
ORTIV laser lancet is a portable, battery-operated laser lancing device, and is indicated for obtaining capillary blood samples in both institutional and at-home settings. The laser is a pulsed Erbium YAG (ER: YAG). It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.
5 Indications / Intended Use
The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.
6 Performance Data
Non-clinical tests for laser lancet:
The safety of laser product, electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards:
- Basic safety and essential performance of the ORTIV is tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1:2020.
- -Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014 +AMD1:2020.
- -Safety of laser product is evaluated in accordance with IEC 60825-1: 2014.
- Risk management was recorded by referring to ISO 14971:2007.
- -Usability was documented by referring to ISO 62366-1:2020.
- Biocompatibility testing per ISO 10993-1 -
7 Substantial Equivalence
The proposed device uses similar or identical technology as the predicate devices and has the same intended uses. Based upon the predicted overall performance characteristics for the ORTIV, MVITRO Co., Ltd., believes that there are no significant differences in usage of its underlying technological principles between the ORTIV and the predicate devices.
8 Conclusions
On the basis of the information provided in this Summary, MVITRO Co., Ltd., believes that the ORTIV is substantially equivalent to legally commercialized predicate devices for the purposes of these 510 (k) submissions.