The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.

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.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called ORTIV, a laser lancing device. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the letter and the accompanying 510(k) summary do not contain any information about clinical study data, acceptance criteria, or performance data beyond non-clinical testing for safety and electrical compatibility.

The provided text only outlines the regulatory clearance process and technical characteristics of the device compared to a predicate device. It explicitly states, "Non-clinical tests for laser lancet: The safety of laser product, electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards." This means the submission was based on non-clinical performance data, likely demonstrating safety and physical/electrical characteristics, rather than clinical performance for accuracy or diagnostic capability, which would be typical for medical imaging AI.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details because this information is not present in the provided FDA 510(k) documentation. The 510(k) summary only lists non-clinical tests for device safety and electrical compliance.

To answer your questions, there would need to be a section detailing clinical performance studies, including:

A table of acceptance criteria and the reported device performance: This would be found in a clinical study report within the 510(k) submission, not typically summarized in the public 510(k) clearance letter or summary.
Sample sizes used for the test set and the data provenance: Clinical study details are needed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Clinical study details are needed.
Adjudication method for the test set: Clinical study details are needed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This implies an AI device, but the ORTIV is a laser lancing device, not an AI diagnostic tool. If it were an AI device, MRMC study results would be needed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this implies an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Clinical study details are needed.
The sample size for the training set: Clinical study details are needed; often for an AI device.
How the ground truth for the training set was established: Clinical study details are needed; often for an AI device.

Conclusion: The provided document is a 510(k) clearance for a physical medical device (laser lancet), not a software device, and it relies on non-clinical safety and performance data for substantial equivalence, not clinical performance data in the context of diagnostic accuracy or AI assistance. Therefore, the specific details you've requested about clinical acceptance criteria, study design (MRMC, standalone), ground truth, and training data are not available in this document.

Summary

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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.

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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

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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

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Indications for Use

Submission Number (if known)

K241646

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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510(k) Summary - K241646

1 General Information

Applicant/Submitter:	MVITRO Co., Ltd.
Address:	2F Hannam Bldg., 254 UN Village-gilYongsan-gu, Seoul, 04420Republic of Korea
Contact Person:	Do Hyun Kim, BT Solutions, Inc.
Address:	Unit 904, Eonju-ro 86gil 5,Gangnam-gu, Seoul 06210, Korea.Tel: +82-2-538-9140Email: ceo@btsolutions.co.krEmail: 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 capillaryblood samples in both institutionaland at-home settings.	indicated for obtaining capillaryblood samples in both institutionaland 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
Mechanismof Action	The laser lancet installed on theORTIV is a pulsed Erbium YAG(ER: YAG) laser. It outputs a singlepulse of laser light with a wavelengthof 2940 nm, which ablates a smallhole in the skin to a depth sufficientto access capillary blood.	The LMT-3000 Laser Skin Perforatoris a pulsed erbium dopedyttriumaluminum- garnet (Er:YAG)laser. It outputs a single pulse of laserlight with a wavelength of 2940 nm,which ablates a small hole in the skinto a depth sufficient to accesscapillary blood.	YES
TechnologyOverview	The wavelength of this laser is 2940nm, which matches water'sabsorption peak. Considering thatwater is the major constituent oforganic tissue, it's possible to explainthe strong absorption of tissue for thiswavelength.On the other hand, due this strongabsorption in water, this laserexhibits a little penetration depth.	The wavelength of this laser is 2940nm, which matches water'sabsorption peak. Taking into accountthat water is the major constituent oforganic tissue, it's possible to explainthe strong absorption of tissue for thiswavelength.On the other hand, due this strongabsorption in water, this laserexhibits a little penetration depth.	YES
BatteryOperated	Rechargeable battery (3.7 Vdc)	Rechargeable battery (3.7 Vdc)	YES
Laser pulserepetitionrate	Single	Single	YES
Anatomicallocation	Fingers	Fingertips	YES
Operatinghumidity	10-90%	Relative humidity 5 to 90%,noncondensing	Similar
Operatingtemperature	10~40°C	Ambient temperature +5 to +40°C	Similar
Storagetemperature	10 ~ 40°C	Ambient temperature -10 to +60°C	Similar
Storagehumidity	10-90%	Relative humidity 5 to 90%,noncondensing	Similar
Sterile	No	No	YES
Material	Polycarbonate	Polycarbonate	YES
Single-Use	No	No	YES
Laser Powerrange	150 mJ (±20%)	Unknown	N/A
Applied parttype	BF	BF	YES
Intended for	Prescription Use	Prescription Use	YES

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ORTIV

510(k) Summary

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510(k) Summary

4 Device Description

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.

Regulation Number and Section

§ 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.