(86 days)
Not Found
No
The device description focuses on the physical principles of laser photodisruption and does not mention any computational or algorithmic components that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated for photodisruption of ocular tissue using a laser to perform therapeutic procedures like capsulotomy and iridotomy, which directly treat a medical condition.
No
The device is described as a laser system used for photodisruption of ocular tissue (e.g., posterior capsulotomy, iridotomy), which involves a therapeutic intervention to treat conditions rather than diagnose them.
No
The device description clearly describes a hardware system including a laser, slit lamp microscope, and aiming system, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The CAPSULO device is a laser system used for surgical procedures on the eye (ocular tissue). It directly interacts with and modifies tissue within the body.
- Intended Use: The intended use clearly describes surgical procedures (photodisruption, capsulotomy, pupillary membranectomy, iridotomy) performed in vivo.
Therefore, the CAPSULO device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
Product codes (comma separated list FDA assigned to the subject device)
HOF
Device Description
The Yttrium Aluminum Garnet (YAG) ophthalmic laser system produces short pulses of focused infrared light at a wavelength of 1.064 nm. These pulses can be precisely positioned using a slit lamp microscope and a dual-point aiming system. The energy contained in a short pulse is concentrated by focusing a very small spot (10 um) so that the formation of plasma is at the focal point. The firing causes an acoustic wave that radiates from the focal point and breaks the near tissue which is known as disruptive photo-effect. Once formed, plasma absorbs and further diffuses incident light, protecting deeper structures. Furthermore, the divergence of the beam after the focal point protects the retina from damage that could otherwise occur by the absorption of concentrated energy in the Nd: YAG treatment beam. As the treatment energy is increased, the size of the plasma formed also increases, until a larger and stronger acoustic wave is produced. For increased energy, it is necessary to focus the treatment beam further behind the ocular structure being treated. The Nd: YAG 1064 nm laser operates at a nano-second pulse rate and the laser energy is delivered to the treatment site using the integrated slit lamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular tissue, eye, retina, lens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, Healthcare Professional
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)
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
- AAMI ANSI ES60601-1 Medical electrical equipment-Part 1: General requirements for . basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic ● safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- . IEC 60601-1-6 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability
- IEC 60601-2-22 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1 Safety of laser products Part 1: Equipment classification and requirements .
- ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5 : Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation . and skin sensitization
Additionally, software verification and validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Major level of concern was provided.
Based on the intended use, technological characteristics, and performance testing, the subject device has been shown to be substantially equivalent to the predicate.
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
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 12, 2022
Quantel Medical % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham. MA 02180
Re: K220430
Trade/Device Name: Capsulo Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HOF Dated: March 11, 2022 Received: March 14, 2022
Dear Maureen O'Connell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anjana Jain, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220430
Device Name CAPSULO
Indications for Use (Describe)
CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K220430 Page 1 of 4
510(k) SUMMARY
Quantel Medical CAPSULO K220430
510(k) Owner
Quantel Medical 1 rue Bois Joli CS40015 63808 Cournon D'Auvergne-Cedex France
Submission Correspondent
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 Phone: 978-207-1245
Date Prepared: May 9, 2022
Trade Name of Device CAPSULO
Common or Usual Name Ophthalmic laser
Classification Name
Ophthalmic Laser; 21 C.F.R. §886.4390 Class II Product Code: HQF
Predicate Device(s) Quantel Medical Optimis Fusion YAG cleared in K140336
Device Description
The Yttrium Aluminum Garnet (YAG) ophthalmic laser system produces short pulses of focused infrared light at a wavelength of 1.064 nm. These pulses can be precisely positioned using a slit lamp microscope and a dual-point aiming system. The energy contained in a short pulse is concentrated by focusing a very small spot (10 um) so that the formation of plasma is at the focal point. The firing causes an acoustic wave that radiates from the focal point and breaks the near tissue which is known as disruptive photo-effect.
4
Once formed, plasma absorbs and further diffuses incident light, protecting deeper structures. Furthermore, the divergence of the beam after the focal point protects the retina from damage that could otherwise occur by the absorption of concentrated energy in the Nd: YAG treatment beam.
As the treatment energy is increased, the size of the plasma formed also increases, until a larger and stronger acoustic wave is produced. For increased energy, it is necessary to focus the treatment beam further behind the ocular structure being treated.
The Nd: YAG 1064 nm laser operates at a nano-second pulse rate and the laser energy is delivered to the treatment site using the integrated slit lamp.
Indications for Use
CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
Substantial Equivalence
Quantel Medical believes that the CAPSULO is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Quantel Medical Optimis Fusion cleared in K140336. The intended use of the CAPSULO is the same as the intended use of YAG mode of the predicate device and the indications for use are also identical to the YAG mode. Both devices are prescription devices for use by trained healthcare providers. Table 1 provides a comparison of the CAPSULO to the predicate device.
| GENERAL SPECIFICATIONS | |||
|---|---|---|---|
| Manufacturer | QUANTEL MEDICAL | QUANTEL MEDICAL | Comparison |
| Model | CAPSULO | OPTIMIS FUSION | |
| (YAG treatment mode) | - | ||
| 510 (K) Number | K220430 | K140336 | - |
| Intended Use | Treatment of ocular | ||
| pathology | Treatment of ocular | ||
| pathology | Substantially equivalent | ||
| Indications for Use | Photodisruption of ocular | ||
| tissue using light energy | |||
| emitted by a Nd:YAG | |||
| laser, including discission | |||
| of the posterior capsule of | |||
| the eye (posterior | |||
| capsulotomy), | |||
| and discission of pupillary | |||
| membranes (pupillary | |||
| membranectomy) in | |||
| aphakic and pseudophakic | |||
| patients, and iridotomy | Photodisruption of ocular | ||
| tissue using light energy | |||
| emitted by a Nd:YAG | |||
| laser, including discission | |||
| of the posterior capsule of | |||
| the eye (posterior | |||
| capsulotomy), | |||
| and discission of pupillary | |||
| membranes (pupillary | |||
| membranectomy) in | |||
| aphakic and pseudophakic | |||
| patients, and iridotomy | Substantially equivalent |
Table 1 CAPSULO Substantial Equivalence
5
| Clearance Type | Prescription | Prescription | Substantially equivalent |
|---|---|---|---|
| User | Healthcare Professional | Healthcare Professional | Substantially equivalent |
| TREATMENT LASERS | |||
| Laser Energy Intensity | Selected by Physician | Selected by Physician | Substantially equivalent |
| Laser Energy source | Q-Switched, Nd: YAG | Q-Switched, Nd: YAG | Substantially equivalent |
| Laser Wavelength | 1064 nm | 1064 nm | Substantially equivalent |
| Pulse setting | 1,2 and 3 pulses per shot, | ||
| selectable | 1,2 and 3 pulses per shot, | ||
| selectable | Substantially equivalent | ||
| Energy Settings | 0.3 – 10 mJ (in 1 pulse) | ||
| 0.6-18 mJ (in 2 pulses) | |||
| 0.9-25.5 mJ (in 3 pulses) | 0.3–10 mJ (in 1 pulse) | ||
| 0.6-18 mJ (in 2 pulses) | |||
| 0.9-30 mJ (in 3 pulses) | Substantially equivalent | ||
| Repetition Rate (Max) | 3 Hz single pulse | ||
| 1.5 Hz double pulse | |||
| 1.5 Hz triple pulse | 2.0 Hz single pulse | ||
| 1.5 Hz double pulse | |||
| 1.5 Hz triple pulse | Substantially equivalent | ||
| Pulse Duration | 4 nanoseconds | 4 nanoseconds | Substantially equivalent |
| Spot Size in air | 10 microns | ||
| (84% energy in diameter) | |||
| 8 microns FWHM | 10 microns | ||
| (84% energy in diameter) | |||
| 8 microns FWHM | Substantially equivalent | ||
| Offset (in air) | 0 to +/- 500μm | Variable | |
| +150μm;0;-150μm | Substantially equivalent. | ||
| AIMING LASERS | |||
| Aiming Beam laser type | Green diode | Red diode | Substantially equivalent |
| Aiming Wavelength | 515 nm | 635±5 nm | Substantially equivalent |
The CAPSULO has similar technological characteristics to the predicate device. Both devices are Q-Switched Nd: YAG lasers with a wavelength of 1064 nm. The pulse settings are identical and the energy settings are the same for 1 and 2 pulses and within the range of the predicate device for 3 pulses. The repetition rate is the same for double and triple pulses but for single pulses is 3 Hz for the CAPSULO compared to 2 Hz for the predicate device. This minor difference in repetition rate does not impact substantial equivalence. Other key laser settings are the same for the two devices with the exception of the offset (in air). The offset of the CAPSULO is 0 to +500 um compared to +150 um. 0, -150 um for the predicate device. This feature in the CAPSULO helps facilitate accurate positioning of the optical breakdown to avoid damage to the retina and lens. Both devices utilize a diode aiming laser and both devices are delivered via a slit lamp. Therefore, the CAPSULO is substantially equivalent to the Optimis Fusion predicate device.
Performance Data
Non-clinical testing was performed to verify that the proposed device met all design specifications and is substantially equivalent to the predicate device.
6
- AAMI ANSI ES60601-1 Medical electrical equipment-Part 1: General requirements for . basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic ● safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- . IEC 60601-1-6 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability
- IEC 60601-2-22 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1 Safety of laser products Part 1: Equipment classification and requirements .
- ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5 : Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation . and skin sensitization
Additionally, software verification and validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Major level of concern was provided.
Based on the intended use, technological characteristics, and performance testing, the subject device has been shown to be substantially equivalent to the predicate.