(205 days)
Not Found
No
The summary describes a low-level laser therapy device and its intended use for pain relief. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on calibration, not algorithmic performance.
Yes
The device is indicated for adjunctive use in the temporary relief of pain, which is a therapeutic purpose.
No
The device is indicated for "temporary relief of pain associated with rotator cuff tendonitis," which is a treatment, not a diagnosis. The description mentions "triggers normal cellular functions" and "applies energy," further indicating a therapeutic purpose.
No
The device description explicitly states it is a "Class II Low Level Laser treatment head" and mentions applying "energy," indicating it is a hardware device that delivers physical treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with rotator cuff tendonitis. This is a therapeutic use, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device is described as a "Low Level Laser treatment head" that applies energy to tissues. This is a physical therapy or treatment device, not a device that analyzes samples from the human body (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rotator cuff
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained health care professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)