(170 days)
The LMT-3000 is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.
The LMT-3000 lancing device uses a battery-powered laser beam (Er:YAG laser technology), which makes a tiny hole in the skin to obtain a capillary blood sample. The LMT-3000 ablates the epidermis and a thin layer of papillary dermis with minimal photothermal and photomechanical damage to the surrounding tissue.
The LMT-3000 is a laser lancing device indicated for obtaining capillary blood samples. The device uses Er:YAG laser technology to ablate the epidermis and a thin layer of papillary dermis to create a small hole for blood collection.
Here's the breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format for performance metrics like "blood sample volume sufficient for analysis" or "pain reduction percentage." Instead, the "acceptance criteria" are implied by the comprehensive non-clinical performance tests and the conclusion drawn from the clinical study that there was "no significant difference in the glucose value between the needle lancet and laser lancet" and that "Some patients in the study reported less pain using the LMT-3000 compared to using the steel lancet."
Therefore, the reported device performance, in relation to implied acceptance, is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Passed testing per ISO 10993-1 |
| Electrical Safety | Passed testing per IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Passed testing per IEC 60601-1-2 |
| Laser Safety | Passed testing per IEC 60825-1 |
| Usability | Passed testing per IEC 60601-1-6 and IEC 62366 |
| Performance in Home Health Care | Passed testing per IEC 60601-1-11 |
| Performance for surgical, cosmetic, therapeutic, diagnostic | Passed testing per IEC 60601-2-22 |
| Software Verification and Validation | Passed testing per IEC 62304/FDA Guidance |
| Cleaning and Sterilization | Passed |
| Storage and Transport | Passed |
| Clinical Equivalence in Glucose Value Acquisition | No significant difference in glucose value detected compared to standard steel lancets. |
| Clinical Advantage in Pain Perception (not quantitative) | Some patients reported less pain compared to steel lancets. |
2. Sample Size and Data Provenance
- Sample Size for the Test Set: 50 patients.
- Data Provenance: The document does not specify the country of origin of the data. The study was "randomized" and appears to be prospective as it involved two visits one week apart and a specific sampling protocol for the LMT-3000 and steel lancets.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the number of experts used to establish ground truth or their specific qualifications for the clinical study. The "ground truth" for glucose values would typically be provided by a calibrated lab instrument, not expert consensus in this context.
4. Adjudication Method
- The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a lancing device for blood collection, not an imaging or diagnostic algorithm that typically involves human readers. The study compares the device's technical performance (glucose value acquisition) and patient experience (pain) directly against a predicate method.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone study was done in the sense that the LMT-3000's primary function (obtaining a blood sample and its impact on glucose measurement) was evaluated directly. There isn't an "algorithm" in the typical AI sense; rather, the device itself is the technology being evaluated for its performance characteristics. The clinical performance study directly assessed the device's ability to facilitate blood collection for glucose analysis.
7. Type of Ground Truth Used
- For the clinical study, the ground truth for performance was primarily glucose values obtained from the collected blood samples. These values would typically be from laboratory analysis using a standard glucose meter or lab equipment. The patient's reported pain also served as a subjective outcome measure.
8. Sample Size for the Training Set
- The document does not mention a training set in the context of machine learning, as the LMT-3000 is a physical medical device, not an AI/ML algorithm requiring a training dataset. The non-clinical tests would have involved various samples of the device itself for validation.
9. How Ground Truth for Training Set was Established
- As there's no mention of a traditional training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply directly here. The "ground truth" for the non-clinical tests (e.g., biocompatibility, electrical safety) is defined by the respective international standards (e.g., ISO 10993-1, IEC 60601-1) and their established pass/fail criteria.
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March 7, 2018
Lameditech Co., Ltd. % Ken Pilgrim Senior Consultant, RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K172818
Trade/Device Name: LMT-3000 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, 2018 Received: February 6, 2018
Dear Ken Pilgrim:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -23 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)
Device Name LMT-3000
Indications for Use (Describe)
The LMT-3000 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)
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
LMT-3000
K172818
1. Submission Sponsor
Lameditech Co., Ltd.
#1002, ACE High End Tower 6th
234, Beotkkot-ro, Geumcheon-gu, Seoul
The Republic of Korea
Contact: Jong Seuk Choi
Title: CEO
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746 USA
Office Phone: (512) 327.9997
Contact: Ken Pilgrim
Title: Senior RA/QA Consultant
3. Date Prepared
October 2, 2017
4. Device Identification
| Trade/Proprietary Name: | LMT-3000 |
|---|---|
| Common/Usual Name: | Laser Lancing Device |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and indermatology |
| Regulation Number: | 21 CFR § 878.4810 |
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Product Code: GEX, Powered Laser Surgical Instrument
Device Class: Class II
Classification Panel: General & Plastic Surgery
5. Legally Marketed Predicate Device(s)
K013021 Innotech USA, Inc. LightLance™ Laser Skin Perforator
6. Indication for Use Statement
The LMT-3000 is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples.
7. Device Description
The LMT-3000 lancing device uses a battery-powered laser beam (Er:YAG laser technology), which makes a tiny hole in the skin to obtain a capillary blood sample. The LMT-3000 ablates the epidermis and a thin layer of papillary dermis with minimal photothermal and photomechanical damage to the surrounding tissue.
8. Substantial Equivalence Discussion
The following table compares the LMT-3000 to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | Lameditech Co., Ltd. | Innotech USA, Inc. |
|---|---|---|
| Trade Name | LMT-3000 | LightLance Laser Perforator |
| 510(k) Number | K172818 | K013021 |
| Product Code | GEX | GEX |
| Regulation Number | 21 CFR § 878.4810 | 21 CFR § 878.4810 |
| Regulation Name | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument |
| Indications for Use | The LMT-3000 is a portable, battery-operated laser lancing device indicatedfor obtaining capillary blood samples. | The LightLance™ Laser Skin Perforator isintended to be used for ablation of skintissue to establish capillary bloodaccess. The LightLance™ Laser SkinPerforator general indication for use isfor the perforation of skin to drawcapillary blood for screening purpose.The device is specifically indicated for |
| Table 5-A - Comparison of Characteristics | ||
|---|---|---|
| Manufacturer | Lameditech Co., Ltd. | Innotech USA, Inc. |
| Trade Name | LMT-3000 | LightLance Laser Perforator |
| obtaining capillary blood samples forsubsequent analysis of blood glucoseconcentration in both institutional andhome settings | ||
| Mechanism of Action | The LMT-3000 Laser Skin Perforator is apulsed erbium doped yttrium-aluminum-garnet(Er:YAG) laser. Itoutputs a single pulse of laser light witha wavelength of 2940 nm, which ablatesa small hole in the skin to a depthsufficient to access capillary blood. | The LightLance Laser Skin Perforator is apulsed erbium doped yttrium-aluminum-garnet (Er:YAG) laser. Itoutputs a single pulse of laser light witha wavelength of 2940 nm, which ablatesa small hole in the skin to a depthsufficient to access capillary blood. |
| Technology Overview | The wavelength of this laser is 2.94 µm,which matches water's absorptionpeak. Taking in to account that thewater 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 laser exhibits alittle penetration depth | The wavelength of this laser is 2.94 µm,which matches water's absorptionpeak. Taking in to account that thewater 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 laser exhibits alittle penetration depth |
| Anatomical Location | Fingertip | Fingertip |
| Conditions of Use | 1. Set the Power Level2. Position the Fingertip3. Press the Discharge button.4. Collect the Blood Sample | 1. Set the Power Level2. Position the Fingertip3. Press the Discharge button.4. Collect the Blood Sample |
| Material | Polycarbonate | Unknown |
| Battery Operated | Rechargeable battery (3.7 Vdc) | Yes |
| Power Supply | 100~240Vac, 50-60 Hz | Not known |
| Output | 5 Vdc, 1.0 A | Not known |
| Applied Parts | BF Type | Not known |
| Laser Source | Er:YAG | Er:YAG |
| Laser Class | Class 4 (IEC 60825-1) | Class 4 (IEC 60825-1) |
| Manufacturer | Lameditech Co., Ltd. | Innotech USA, Inc. |
| Trade Name | LMT-3000 | LightLance Laser Perforator |
| Laser Pulse RepetitionRate | Single | Single |
| Laser wavelengthspectrum | 2940 nm ± 10% | 2940 nm ± 10% |
| Degree of protectionagainst ingress ofwater or particulatematter | IP22 | Not known |
| Unit Dimensions | 34.9 (W) X 102.45 (D) X 132.2 mm (H) | Not known |
| Weight | 170 g | Not known |
| OperatingTemperature | Ambient temperature +5 to +40°C | Not known |
| Operating Humidity | Relative humidity 5 to 90%,noncondensing | Not known |
| Storage Temperature | Ambient temperature -10 to +60°C | Not known |
| Storage Humidity | Relative humidity 5 to 90%,noncondensing | Not known |
| Single-Use | No | No |
| Battery Type | 3.7 Li-Polymer Battery 700 mAh,rechargeable, replaceable (Type ICR-18350) | Not known |
| Sterile | No | No |
| Complies with ISO10993-1 | Yes | Yes |
| Electrical SafetyTesting Passed | Testing passed | Testing passed |
| Conditions of Use | Rx Only | Rx Only |
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5. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of LMT-3000 and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Lameditech Co., Ltd. completed a number of non-clinical performance tests. The LMT-3000 meets all the requirements for overall design,
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biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The LMT-3000 passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support the safety and efficacy of the subject device.
- . Biocompatibility testing per ISO 10993-1
- . Electrical safety testing per IEC 60601-1
- . Electromagnetic Compatibility (EMC) testing per IEC 60601-1-2
- . Laser Safety per IEC 60825-1
- . Usability per IEC 60601-1-6 and IEC 62366
- . Performance of Home Health Care Equipment per IEC 60601-1-11
- Performance of surgical, cosmetic, therapeutic and diagnostic equipment per IEC 60601-2-22
- . Software verification and validation testing per IEC 62304/FDA Guidance
- Cleaning and Sterilization Testing - pass
- . Storage and Transport Testing - pass
6. Clinical Performance Data
To validate the performance, safety, and effectiveness of the LMT-3000 and to demonstrate substantial equivalence to the predicate device, a randomized study was conducted comparing the LMT-3000 to standard steel lancets.
A total of 50 patients were evaluated between two visits, one week apart, for both the LMT-3000 and steel lancets. The sampling was done with the right hand first and the left hand subsequently for all subjects. During the first visit, half (25) of 50 subjects were sampled with the needle lancets on the right hand and with laser lancet on left hand. Another half of 50 subjects were sampled with the laser lancet on the right hand and with the needle lancet on left hand. During the second visit, the same procedures were done in the opposite order.
Analysis on the resultant glucose values indicated no significant difference in the glucose value between the needle lancet and laser lancet. There were no dropouts from either arm of the study group.
Some patients in the study reported less pain using the LMT-3000 compared to using the steel lancet for obtaining blood samples on some occasions.
7. Statement of Substantial Equivalence
lt has been shown in this 510(k) submission that the differences, between the LMT-3000 device and the predicate device listed above, do not raise new types of questions regarding safety and effectiveness. Further, the LMT-3000 device utilizes the same type of technology as the predicate device. The LMT-3000, as designed and manufactured, is determined to be substantially equivalent to the above-listed predicate device.
§ 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.