(695 days)
The LTU-904 is indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.
The LTU-904 Laser Therapy Unit is a hand-held battery powered treatment device, is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye.
Here's a breakdown of the acceptance criteria and study details for the Rian Corp LTU-904 Portable Laser Therapy System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner typical for a device's performance benchmarks. Instead, it describes clinical outcomes that demonstrate the device's effectiveness. The closest approximation to acceptance criteria would be the clinically significant improvements observed.
Interpretation of "Acceptance Criteria" based on reported study outcomes: The device is considered effective if it significantly reduces lymphedema volume, extracellular fluid (ECF), and is well-tolerated (no adverse effects).
| Acceptance Criteria (Implied from Study Outcomes) | Reported Device Performance (LTU-904 Active Treatment) | Placebo/Control Performance |
|---|---|---|
| Reduction in affected arm volume (minimum 200 mL) | 31% of participants receiving 2 cycles of treatment (3 months after second cycle) achieved a ≥200 mL reduction. ~20% in Intent-to-Treat (ITT) analysis after 2nd active cycle. | 4% of those who received one cycle of placebo treatment. |
| Significant reduction in Extracellular Fluid (ECF) | 52% of participants experienced a clinically significant decrease in ECF after 6 weeks of active laser. ECF significantly reduced in affected arm, trunk, and unaffected arm. | 19% of people who had placebo treatment achieved the same reduction. |
| Safety / Adverse Effects | No adverse effects from the laser treatments were observed by the investigators. | Not explicitly stated for placebo, but generally expected to be none related to sham. |
2. Sample Size and Data Provenance
- Sample Size (Test Set): A total of 64 post-mastectomy patients with at least 200 ml difference between their arms were enrolled in the study.
- Data Provenance:
- Country of Origin: Adelaide, Australia.
- Retrospective or Prospective: The study was a prospective placebo-controlled double-blind clinical trial.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish "ground truth" in the sense of independent expert review of images or diagnoses. Instead, the ground truth for treatment efficacy was established through objective clinical measures and subjective patient assessments.
- Experts: The study was conducted at Flinders Medical Centre in Adelaide, Australia, under ethics committee approval. The assessments (ECF, whole arm volume, tonometry) were presumably performed by trained medical staff/researchers at the center. No specific number or qualifications for independent 'expert review' of outcomes are detailed beyond the conduct of the trial by clinical investigators.
4. Adjudication Method
The document describes the clinical trial design rather than an adjudication method for a test set.
- Trial Design: The study was a placebo-controlled double-blind clinical trial. This means neither the participants nor the researchers administering the treatment and assessing outcomes knew whether the active or sham laser was being used. This inherently minimizes bias in assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the document describes a clinical trial comparing an active device to a placebo, not a comparative effectiveness study involving multiple human readers assessing cases with and without AI assistance.
6. Standalone (Algorithm Only) Performance
- Was a standalone study done? No, the device is a therapeutic laser system, not an algorithm. Its performance is assessed directly on patient outcomes in a clinical trial setting.
7. Type of Ground Truth Used
The "ground truth" for the device's effectiveness was established through:
- Objective Clinical Measurements:
- Extra Cellular Fluid (ECF)
- Whole arm volume
- Tonometry (tissue hardness)
- Subjective Measures: Although not detailed, the text mentions "subjective measures" were used alongside objective ones.
8. Sample Size for the Training Set
- The document describes a clinical trial for evaluating device performance, not a study for training an algorithm or AI model. Therefore, there is no "training set" in the context of machine learning. The 64 patients were part of the evaluation study (test set).
9. How the Ground Truth for the Training Set was Established
- As there was no training set for an algorithm, this question is not applicable. The ground truth for the clinical trial patients (the "test set" in this context) was established by the objective and subjective measures outlined in point 7.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rian Corp Pty Ltd c/o Ms. P. Ann Angel Executive Director 2/331 Seaview Road Henley Beach South Australia 5022 Australia
OCT 2 6 2006
Re: K030295
Trade/Device Name: Rian Corp LTU-904 Portable Laser Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NZY Dated: March 9, 2006 Received: April 20, 2006
Dear Ms. Angel:
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.
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
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Page 2 - Ms. P. Ann Angel
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Director Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K030295 LTU-904 Portable Laser Therapy Unit – Device Name:
Indications for Use:
The LTU-904 is indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.
Prescription Use______________________________________________________________________________________________________________________________________________________________ X (Part 21CFR801 Subpart D) and/or
Over –The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Center for Devices and Radiological Health
510(k) Number K030295
\\DC - 071676/000630 - 2353081 v1
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510(k) SUMMARY
Riancorp Pty Ltd.'s LTU-904 Portable Laser Therapy Unit
Submitter's and Sponsor's Name, Address, Telephone Number, Contact Person
Riancorp Pty Ltd 7 Fleet Street Richmond South Australia 5033
Phone: 61-8-8232 8822 Facsimile: 61-8-8232 8833
Contact Person: Ms. Patricia Ann Angel
Date Prepared
September 2006
Name of Device
LTU-904 Portable Laser Therapy Unit
Common or Usual Name
Low Level Laser Therapy Device
Classification Name
Non-heating Lamp for Adjunctive Use in Pain Therapy (21 C.F.R. 8890.5500)
Predicate Devices
MicroLight Corporation of America's MicroLight 830 Acculaser, Inc.'s Acculaser Pro Low Level Laser Therapy
Indications for Use
The LTU-904 is indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.
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Technological Characteristics
The LTU-904 Laser Therapy Unit is a hand-held battery powered treatment device, is non-thermal and delivers a controlled series of 200 ns bursts of pulses of 904nm laser beam, which is in the near infrared spectrum that is invisible to the human eye.
The LTU-904 is classified as a Class I Laser according to the USA FDA 21 CFR 1040.10 and 1040.11 regulations.
Performance Data
LTU-904 for the Treatment of Post Mastectomy Lymphedema
Many patients suffer from arm swelling after breast cancer treatment. This is usually associated with radiotherapy and lymph node clearance. Surgery to the lymph nodes may interfere with lymph drainage. The surgery can cause a significant reduction in Lymphatic Transport Capacity (the ability of the system to clear this fluid). The scarring of surgery will also inhibit lymph flow through the area and inhibit regeneration of new vessels.
When Lymphatic Load exceeds (amount of fluid in the tissues waiting to be taken away) the Lymphatic Transport Capacity Ivmph accumulates in the tissues and lymphedema results. Lymphedema swelling often causes discomfort and feelings of heaviness, tension, loss of range of movement and is usually treated with compression and massage therapies. LTU-904 laser therapy is an additional tool for the treatment of post mastectomy lymphedema.
The Riancorp LTU-904 laser therapy unit was evaluated in a placebo controlled double blind clinical trial of post mastectomy lymphedema patients which has been published in a peer-reviewed journal. The study was conducted at Flinders Medical Centre in Adelaide, Australia, under ethics committee approval.
A total of 64 post mastectomy patients with at least 200 ml difference between their arms were enrolled in the study. The patients were randomized to receive one cycle (3 weeks) of either active or sham laser and then were evaluated 2 to 3 months later using objective and subjective measures. After the first cycle of treatment, the control patients were offered active treatment and the original treatment arm was given a second round (block) of laser therapy. These patients were again assessed 2 to 3 months after their second cycle of treatment.
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Patients were assessed for extra cellular fluid (ECF), whole arm volume and tonometry (tissue hardness). Results indicated:
- · Volume of the affected arm was reduced by a minimum of 200 mL in 31% of participants who received 2 cycles of treatment, 3 months after their second cycle of active LTU-904 therapy. In an Intent-to-Treat (ITT) analysis, where all patients lost to follow-up or with missing data were considered failures, approximately 20% of the subjects met the 200 mL criteria following their 2nd active treatment cycle. This is compared to 4% of those who received one cycle of placebo treatment.
- · ECF was significantly reduced following 6 weeks of LTU-904 therapy, in: (1) the affected arm (immediately after the course of treatment and maintained at 1 and 3 month follow-up); (2) the trunk (immediately after the course of treatment and maintained at 1 month follow-up); and (3) the unaffected arm (immediately after treatment).
52% of participants experienced a clinically significant decrease in ECF after 6 weeks of active laser. In contrast only 19% of people who had placebo treatment achieved the same reduction.
No adverse effects from the laser treatments were observed by the investigators. This study demonstrated that in all treatments of post mastectomy lymphedema, the LTU-904 functioned as intended.
Substantial Equivalence
The LTU-904 has no significant changes or modifications compared to the predicate products that effect safety, effectiveness, or the device's intended use of applying low level laser therapy to tissues. The following technological characteristics are the differences between the LTU-904 and predicate devices:
Laser wavelength. The LTU-904 device and the MicroLight 830 and Acculaser Pro LLLT all use laser diodes with wavelengths in the near infrared region. The difference in these wavelengths is clinically insignificant due to the closeness of the wavelengths and because these differences do not impact the depth of penetration or absorption in tissue.
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- Laser Safety Class. Due to the design and construction of the LTU-904 device it is a Class I Laser device according to the USA FDA 21 CFR 1040.10 and 1040.11 regulations whereas the other predicate devices are all Class 3B. This is not a significant issue due to the fact
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that the LTU-904 device has a lower classification and has been validated clinically to support the device's indications for use.
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- Maximum Laser Power. The LTU-904 has a maximum average laser power of 5.0 mW whereas the other devices are rated at 30 mW. This is not a significant issue due to the fact the LTU-904 device has a lower maximum power and has been validated clinically to support the device's indications for use.
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- Laser Mode of Operation. The LTU-904 uses a pulsed output laser beam instead of a continuous wave (CW) output. The pulsing frequency is high (2.5 KHz for the low setting and 5.0 KHz for the high setting) and the pulse duration is 200 ns. Clinical data supports that this mode of operation, where high peak power (yet low average power) when delivered to the patient, achieves clinically significant results.
Compared to its predicate devices, the LTU-904 device has similar technological characteristics, principles of operation, and a similar intended use of delivering low level laser therapy to tissues. The minor technological differences between the LTU-904 and its predicate devices raise no new type issues of safety or effectiveness. Moreover, clinical performance data demonstrate that the LTU-904 is as safe and effective as its predicates. Thus, the LTU-904 is substantially equivalent.
§ 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.