(205 days)
The LD-I-75 and LD-I-200 "" treatment heads are indicated for adjunctive use in the temporary relief of pain associated with rotator cuff tendonitis.
The BioFlex™ System and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, and low cost benefit to the patient, the practitioner and the health care system.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
This device (LD-I 75 and LD-I 200™) is a low-level laser treatment head, classified as a Class II device (21 CFR part 890.5500, Product Code NHN) for adjunctive use in pain therapy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Indication: Temporary relief of pain associated with rotator cuff tendonitis. | "The scientific concept on which this device is based is the principle that by stimulating a local area with low level laser, pain is relieved." |
| Functional Safety & Calibration | "A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life). The BioFlex® System and related Treatment Heads has benefited from design, development, testing and production procedures that conform to Quality Systems." |
| Substantial Equivalence | The FDA determined the device is substantially equivalent to legally marketed predicate devices (K010175, K043353, K050342). |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific clinical study with a test set designed to evaluate the efficacy of the LD-I 75 and LD-I 200™ for pain relief or for its intended use. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to quality systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as no clinical study with a test set is described in the provided document.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical study with a test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. This type of study is more common for diagnostic imaging devices where human reader performance is a key metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device described is a physical medical device (low-level laser treatment heads) and not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.
7. The Type of Ground Truth Used
The 510(k) summary does not describe the use of ground truth in the context of a clinical study for efficacy. The core of the submission for this device type typically relies on:
- Scientific Principle: The belief that stimulating with a low-level laser relieves pain.
- Predicate Device Comparison: Demonstration of substantial equivalence to already approved devices.
- Manufacturing Quality Assurance: Verification through factory calibration and quality system conformance.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm.
Summary of Missing Information and Context:
It's crucial to understand that for a physical therapy device like a low-level laser, the 510(k) pathway often relies heavily on demonstrating substantial equivalence to already legally marketed devices. This means that extensive new clinical studies to prove efficacy (like those with large test sets, ground truth establishment by experts, or MRMC studies) are often not required if the new device can show it's "as safe and effective" as a predicate device with similar indications for use and technological characteristics.
The provided document highlights the scientific concept behind the device and its adherence to quality systems. The FDA clearance is based on this substantial equivalence, rather than a detailed efficacy study with a specific test set.
{0}------------------------------------------------
510K Summary
APR - 2 2008
K072551
LD-1 75 and LD-1 200 tm 10 August 2007
| Sponsor | Consultant |
|---|---|
| Meditech International Inc. | Mr. Richard Keen |
| 411 Horner Ave., Unit #1 | Compliance Consultants |
| Etobicoke, Ontario, | 1151 Hope Street |
| Canada M8W 4W3 | Stamford, CT 06907-1659 |
| Voice 416 251 1055 | Voice 203 329 2700 |
| Fax 416 251-2446 | Fax 203 329 2345 |
| Email: mslonchka@meditech-bioflex.com | Email: rkeen@fda-complianceconsultants.com |
| Proprietary Name: | LD-I 75 and LD-I 200tm |
| Common Name: | LD-I 75 and LD-I 200tm |
| Device Classification Name: | lamp, non-heating, for adjunctive use in pain therapy |
| Classification Number: | 21 CFR part 890.5500 |
| Product Code: | NHN |
| Device Classification: | Class II |
| Establishment registration No. : | Not applicable (foreign manufacture) |
| Predicate Device: | K010175, K043353, K050342 |
Trademark Notice: All Trademarks used other than those of Meditech International are registered to their respective owners.
Confidentiality notice: All data contained in this application and all appendixes provided with his appendix or aided trade secrets or proprietary data which the sponsor requests are treated in accordance with law.
Device Description
The BioFlex™ System and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, and low cost benefit to the patient, the practitioner and the health care system.
Intended Use
The intended use of this device is for trained health care professionals to incorporate this technology into his/her scope of practice for the benefit of the patient and to treat those patients with specific pathologies using specific protocols.
Technological Characteristics and Substantial Equivalence
The scientific concept on which this device is based is the principle that by stimulating a local area with low level laser, pain is relieved.
Performance Testing
A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life). The BioFlex® System and related Treatment Heads has benefited from design, development, testing and production procedures that conform to Quality Systems.
Meditech International Inc.
Page 12
LD-1 75 & LD-I 200 ™
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Meditech International, Inc. % Compliance Consultants Mr. Richard Keen 1151 Hope Street Stamford, Connecticut 06907
Re: K072551
Trade/Device Name: LD-I-75 and LD-I-200™ Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: NHN Dated: March 3, 2008 Received: March 5, 2008
Dear Mr. Keen:
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.
APR - 2 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
{2}------------------------------------------------
Page 2 - Mr. Richard Keen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(K) Number (If known): K072551
Device Name: LD-I-75 and LD-I-200 tml
The LD-I-75 and LD-I-200 "" treatment heads are indicated for adjunctive use in the temporary relief of pain associated with rotator cuff tendonitis.
Netrkeal for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072551
Prescription Use __ XXX (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)
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.