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The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.

This document describes the 510(k) summary for Biolitec's 15W Ceralas D 1470nm Diode Laser (Model D1470). It is a special 510(k) notice for a modification to a previously cleared device. The primary claim is substantial equivalence to predicate devices, rather than a de novo clinical study proving novel performance. Therefore, many of the typical acceptance criteria and study details for a new device are not explicitly present in this summary.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in this 510(k) summary. The basis for clearance is "substantial equivalence" to existing legally marketed devices.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set or clinical study with a specific sample size designed to prove the device meets acceptance criteria. The clearance is based on substantial equivalence to predicate devices. This typically involves demonstrating that the modified device does not raise new questions of safety or effectiveness compared to a device already on the market, often through bench testing, engineering analysis, and a comparison of design specifications. Therefore, there is no explicit test set data with a sample size or data provenance mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. As no explicit clinical test set or study is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no explicit clinical test set or study is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. This 510(k) summary focuses on demonstrating substantial equivalence of a modified device, not on comparative effectiveness against human readers or other devices in an MRMC setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Ceralas D1470 is a surgical laser, not an diagnostic algorithm or AI system. Its performance is related to its physical properties and clinical application by a surgeon.

7. Type of Ground Truth Used

Not explicitly stated in terms of a clinical ground truth for a study. The "ground truth" for the substantial equivalence claim is the established safety and effectiveness of the existing predicate devices (Biolitec's previously cleared Ceralas D1470 and Cool Touch CTEV 1320 Nd: YAG Laser).

8. Sample Size for the Training Set

Not applicable. This device is a laser, not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is a laser, not a machine learning algorithm.

In summary:

The provided 510(k) summary for the Biolitec Ceralas D 1470nm Diode Laser demonstrates substantial equivalence to predicate devices (Biolitec's previously cleared Ceralas D1470 and the Cool Touch CTEV 1320 Nd: YAG Laser) for its safety and effectiveness. This strategy for regulatory clearance does not typically involve the detailed clinical study methodologies (e.g., test set sample sizes, expert ground truth, MRMC studies) that would be common for novel diagnostic devices incorporating AI or requiring de novo clinical validation. The acceptance criteria essentially revolve around demonstrating that the modified device does not introduce new safety or effectiveness concerns compared to its predicates.

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1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:

1. Laser console;
2. Internal computer;
3. Control panel and display;
4. Optical delivery system;
5. Hand set with integrated cooling (chilled sapphire optical window);
6. Foot switch
   The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.

The provided text does not describe specific acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving performance against predefined acceptance criteria through a clinical study.

Here's a breakdown of why this information is absent and what the document does provide:

• No Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" and "Nonclinical Performance Data: None." This immediately tells us that no studies were conducted to gather performance metrics against acceptance criteria for this specific device.
• Substantial Equivalence: The conclusion states: "The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser shares the same indications for use, similar design features (including wavelengths, laser medium, power supply, cooling and control systems), functional features (including power output, repetition rate, energy, spot sizes and energy fluence), and is therefore substantially equivalent to the above legally marketed laser systems currently in commercial distribution." This is the core of a 510(k) submission – demonstrating similarity to a device already on the market, avoiding the need for new clinical trials in many cases.

Therefore, for the specific questions asked, the answers are largely "Not applicable" or "None provided" based on the nature of this 510(k) submission.

Here's how to answer based on the provided document, addressing each point:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable, as no clinical or performance test set data specific to this device is provided.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable.

5. 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

• MRMC Comparative Effectiveness Study: No, not applicable. This is a laser device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: No, not applicable. This is a physical laser device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable, as no clinical study or performance data generation for this specific device is described.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable, as no algorithm training or clinical study for this device is described.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable.

Summary based on the document:

This 510(k) submission for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. No new clinical performance data, nonclinical performance data, or studies (such as those involving test sets, training sets, experts, or multi-reader studies) were submitted for this specific device. The device's approval is based on its similar design, functional features, and indications for use as compared to the listed predicate devices.

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