(68 days)
For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surgery.
Accu-Pulse 1000 is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).
Here's an analysis of the provided 510(k) summary regarding the Accu-Pulse 1000 CO2 Surgical Laser System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present "acceptance criteria" in the format of pass/fail metrics with associated studies for the Accu-Pulse 1000 CO2 Surgical Laser System. Instead, it relies on demonstrating substantial equivalence to a previously marketed predicate device (Accu-Pulse pulsed CO2 laser). The "reported device performance" is essentially a comparison of specifications to the predicate device and another similar device.
Here's a table based on the provided "Table of Substantial Equivalence":
| Feature | Acceptance Criteria (Predicate Device K971830) | Reported Device Performance (Accu-Pulse 1000) | Meets Criteria? |
|---|---|---|---|
| Power | 1-15 Watts | 1-15 Watts | Yes |
| Wavelength | 10.6 microns | 9.6 or 10.6 microns | (See Note 1) |
| Indications for Use | Coagulation, vaporization, ablation of or cutting of soft tissue in dermatology, plastic surgery, podiatry and otorhinolaryngology | Coagulation, vaporization, ablation of or cutting of soft tissue in dermatology, plastic surgery, podiatry and otorhinolaryngology | Yes |
| Laser Type | DC slab excited | DC slab excited | Yes |
| Spot Size | 3mm, 5mm & 7mm | 250 microns-3mm | (See Note 2) |
| Average Power | 1-15 Watts | 1-15 Watts | Yes |
| Mode | Multi-mode | TEM 00 | (See Note 3) |
| Exposure Duration | 4 us | 4-10 ps | (See Note 4) |
| Control System | Microprocessor, self diagnosis | Microprocessor, self diagnosis | Yes |
| Repetition Rate | 0.5-5Hz | 1-20 Hz | (See Note 5) |
| Aiming Beam | 633 nanometer | 633 nanometer | Yes |
| Excitation | DC excited | DC excited | Yes |
Notes on "Meets Criteria?":
- Wavelength: The Accu-Pulse 1000 offers an additional wavelength (9.6 microns) which is a difference from the predicate. The FDA's approval indicates this difference was considered acceptable for substantial equivalence, likely due to similar tissue interaction properties or it being an enhancement.
- Spot Size: The Accu-Pulse 1000 has a significantly different spot size range (250 microns-3mm) compared to the predicate (3mm, 5mm & 7mm). This represents a change in performance/capability. Again, the FDA's approval implies this was deemed acceptable for substantial equivalence, perhaps offering more precise control.
- Mode: The Accu-Pulse 1000 operates in "TEM 00" mode, while the predicate is "Multi-mode". TEM 00 (Transverse Electromagnetic Mode 00) is often referred to as a Gaussian mode and typically provides a more focused and precise beam profile compared to multi-mode. This is a significant difference in laser beam quality and performance. The FDA's acceptance suggests this change was considered an improvement or not a significant safety/effectiveness difference that would preclude substantial equivalence.
- Exposure Duration: The Accu-Pulse 1000's exposure duration is in picoseconds (ps) versus microseconds (us) for the predicate. This is a massive difference (picoseconds are orders of magnitude shorter than microseconds). Ultrafast lasers (picosecond/femtosecond) have very different tissue interaction characteristics (e.g., photoablation with minimal thermal damage). This is a major technological change and would typically require a strong justification for substantial equivalence if the indications for use remain the same. The FDA's approval implies this difference was considered acceptable.
- Repetition Rate: The Accu-Pulse 1000 has a higher repetition rate (1-20 Hz) compared to the predicate (0.5-5Hz). This allows for faster treatment.
Study That Proves the Device Meets Acceptance Criteria:
The document explicitly states: "Performance Data: None. The specifications and intended use of the Accu-Pulse 1000 Surgical Laser System are the same or very similar to those of the Accu-Pulse pulsed CO2 laser. Because of this, performance data were not required."
Therefore, there was no specific study conducted to prove the Accu-Pulse 1000 meets acceptance criteria in the traditional sense of comparative clinical or non-clinical performance data. The device's acceptance was based on a demonstration of substantial equivalence to a predicate device, arguing that its design and performance specifications are comparable or improved such that new safety and effectiveness concerns are not raised.
Detailed Information based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. No performance data or test set was used for substantial equivalence.
- 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)
- Not applicable. No ground truth was established by experts for a test set. Substantial equivalence was determined by comparing technical specifications and intended use with a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
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
- Not applicable. This is a surgical laser system, not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The basis for approval was substantial equivalence to a predicate device, rather than performance against a defined ground truth derived from clinical data. The "ground truth" in this context is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model requiring a training set. The mention of "Software Development Procedure" and "software will be verified and validated" refers to internal software quality assurance processes for the device's control system, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as above. The software validation mentioned refers to standard software engineering practices (verification against specifications, validation through testing against intended use and intentional breaches/breaks to confirm safety interlocks and input parameters), not ground truth for a machine learning model.
§ 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.