(91 days)
Not Found
No
The summary describes a passive laser fiber and its physical properties, with no mention of AI or ML.
Yes.
The device is used for "ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures," which are therapeutic actions.
No
The device is described as a "Single Use CO2 Laser Fiber" used for "ablation, excision, incision, and vaporization of soft tissue." These are therapeutic actions, not diagnostic ones. The device description and intended use focus on altering tissue, not detecting conditions.
No
The device description clearly details a physical, single-use CO2 laser fiber with specific material composition, dimensions, and connectors. It is a hardware component designed to be coupled with a laser system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of this device is for the "ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures." This is a surgical tool used directly on the patient's body during a procedure.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the body. The device interacts directly with the tissue.
Therefore, based on the provided information, this Single Use CO2 Laser Fiber is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Single Use CO2 Laser Fiber is indicated for the ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Single Use CO2 laser fiber is a single use hollow fiber compatible to CO2 laser systems with the following specifications:
- equipped with F-SMA receptacle connector; ●
- equipped with a CO2 laser source, emitting radiation at 10.6 µm wavelength with pulsed and continuous wave (CW) emission mode;
- . able to produce a beam of maximum 300 µm diameter with maximum 30 mrad divergence at the fiber input plane;
- . with a maximum power of 40 W;
- equipped with an internal compressed air delivery system capable to generate a positive air flow ● inside the fiber tube;
The main technical specifications are reported in Table 1.
| D1 (μm) | 500 |
|---|---|
| D2 (μm) | 650 |
| D3 (μm) | 1040 |
| Numerical aperture | 0.04 |
| Fiber length (m) | 2 |
| Connector | SMA905 |
| Tip length (mm) | 3 |
| Number of uses | 1 |
| Sterilization method | EtO |
| Shelf life | 5 years |
| Power transmission | 60-70% |
| Short term minimum bending radius | 4 cm at 120° |
| Packaging | Double pouch |
Table 1: Fiber main specifications. D1-3 are reported in Figure 1.
The fiber structure is reported in Figure 1. It is composed of two layers: a capillary tube made of fused silica and a jacket made of ETFE. The cavity is covered by two films: the outer one is made of silver and the inner one is made of silver iodide. Silver, due to its high reflectivity, allows laser beam reflection and, thus, propagation inside the cavity. The addition of a silver iodide film from oxidation. A summary of fiber materials is reported in Table 2. Such materials represent patient contacting materials. D1, the lumen diameter, also corresponds to the laser beam diameter.
Figure 1: Optical fiber section. De are the different layers. A, B, C, D represent the different layers whose materials are reported in Table 2.
| Material Layer | ||
|---|---|---|
| A | Jacket | ETFE (Tefzel) |
| B | Capillary tube | Fused Silica |
| C | Outer coating | Silver |
| D | Inner coating | Silver iodide |
Table 2: Fiber materials
Optical fiber main components are shown in Figure 2. It is equipped with a SMA905 connector to be coupled to the laser system and a code plug that, for laser systems equipped with a code plug connector, allows the laser device to detect the fiber presence. A protective cap, to be removed before use, is placed on the fiber tip. Strain relief protects the fiber from mechanical stress at the connector side.
Figure 2: Fiber main components.
This kind of fiber needs to be connected to a laser system with an internal compressed air system. An air flow inside the fiber lumen is necessary to both cool the fiber and keep it free from debris.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, excluding heart or central circulatory system, or the central nervous system.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 tests:
- Biocompatibility: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Pyrogenicity performed with positive results according to ISO 10993-1: 2018.
- Packaging validation: Device packaging assessed after accelerated ageing to simulate 5 years shelf life according to ISO 11607-1: 2019 and ISO 11607-2: 2019.
- Sterilization validation: EtO sterilization validation performed for both sterilization sites (Steril Verona and Steris) according to ISO 11135: 2014.
- Performance (laser transmission and minimum bending radius): Verified that laser transmission is within 60 and 70% in both normal conditions and with the fiber bent at the minimum bending radius at both 25 and 40W.
Key results: The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively.
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
February 19, 2025
Quanta System SpA Dario Bandiera Regulatory Affairs Manager Via Acquedotto 109 Samarate, VA 21017 Italy
Re: K243588
Trade/Device Name: Single Use CO2 Laser Fiber (HAF005001) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 6, 2024 Received: November 20, 2024
Dear Dario Bandiera:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
2
assistance/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,
TANISHA L. HITHE - C Date: 2025.02.19
L. HITTHE - C Date: 2025.02.19
L. HITTHE - - 3 14:10:59 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243588
Device Name Single Use CO2 Laser Fiber (HAF005001)
Indications for Use (Describe)
Single Use CO2 Laser Fiber is indicated for the ablation, excision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures. Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K243588 - 510(k) Summary
| Applicant /
manufacturer: | Quanta System S.p.A., Via Acquedotto 109, 21017
Samarate (VA), Italy |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dario Bandiera
RA Manager
Quanta System S.p.A.
Email: dario.bandiera@quantasystem.com
Phone: +39-0331-376797 |
| Date Prepared: | 6th November 2024 |
| Model name: | Single Use CO2 Laser Fiber (HAF005001) |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and
plastic surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Predicate device | ProFlex CO2 Laser Fiber (K203799) manufactured by
InnovaQuartz LCC. |
5
1 Abbreviations
ETFE= Ethylene tetrafluoroethylene EtO= Ethylene oxide
Device description 2
Single Use CO2 laser fiber is a single use hollow fiber compatible to CO2 laser systems with the following specifications:
- equipped with F-SMA receptacle connector; ●
- equipped with a CO2 laser source, emitting radiation at 10.6 µm wavelength with pulsed and continuous wave (CW) emission mode;
- . able to produce a beam of maximum 300 µm diameter with maximum 30 mrad divergence at the fiber input plane;
- . with a maximum power of 40 W;
- equipped with an internal compressed air delivery system capable to generate a positive air flow ● inside the fiber tube;
The main technical specifications are reported in Table 1.
| D1 (μm) | 500 |
|---|---|
| D2 (μm) | 650 |
| D3 (μm) | 1040 |
| Numerical aperture | 0.04 |
| Fiber length (m) | 2 |
| Connector | SMA905 |
| Tip length (mm) | 3 |
| Number of uses | 1 |
| Sterilization method | EtO |
| Shelf life | 5 years |
| Power transmission | 60-70% |
| Short term minimum | 4 cm at 120° |
| bending radius | |
| Packaging | Double pouch |
Table 1: Fiber main specifications. D1-3 are reported in Figure 1.
The fiber structure is reported in Figure 1. It is composed of two layers: a capillary tube made of fused silica and a jacket made of ETFE. The cavity is covered by two films: the outer one is made of silver and the inner one is made of silver iodide. Silver, due to its high reflectivity, allows laser beam reflection and, thus, propagation inside the cavity. The addition of a silver iodide film from oxidation. A summary of fiber materials is reported in Table 2. Such materials represent patient contacting materials. D1, the lumen diameter, also corresponds to the laser beam diameter.
6
Image /page/6/Figure/0 description: The image shows a diagram with four labeled circles, A, B, C, and D. There are also three labeled measurements, D1, D2, and D3, which appear to be diameters of the circles. The circles are nested within each other, with circle A being the largest and circle D being the smallest.
Figure 1: Optical fiber section. De are the different layers. A, B, C, D represent the different layers whose materials are reported in Table 2.
| | Material
Layer | |
|---|-------------------|---------------|
| A | Jacket | ETFE (Tefzel) |
| B | Capillary tube | Fused Silica |
| C | Outer coating | Silver |
| D | Inner coating | Silver iodide |
| Table 2: Fiber materials | ||||
|---|---|---|---|---|
| -------------------------- | -- | -- | -- | -- |
Optical fiber main components are shown in Figure 2. It is equipped with a SMA905 connector to be coupled to the laser system and a code plug that, for laser systems equipped with a code plug connector, allows the laser device to detect the fiber presence. A protective cap, to be removed before use, is placed on the fiber tip. Strain relief protects the fiber from mechanical stress at the connector side.
Image /page/6/Figure/5 description: The image shows a fiber optic cable with several labeled components. At the top right, a "Tip protective cap" is placed over the end of the fiber. Moving counter-clockwise, the fiber is labeled, and then a "Code plug" is in the middle of the cable. At the end of the cable is an "SMA connector" with "Strain relief".
Figure 2: Fiber main components.
This kind of fiber needs to be connected to a laser system with an internal compressed air system. An air flow inside the fiber lumen is necessary to both cool the fiber and keep it free from debris.
3 Indication for use
Single Use CO2 Laser Fiber is indicated for the ablation, coagulation, excision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
Indications involving heart or central circulatory system, or the central nervous system are excluded from optical fibers intended use.
7
Comparison with predicate 4
In Table 3 the main specifications of the subject device are summarized and compared to the predicate device. ProFlex CO2 Laser Fiber (InnovaQuartz LCC) has been selected as predicate device.
| Subject device | Predicate device | Equivalence rationale | |
|---|---|---|---|
| Model n° | Single Use CO2 laser fiber | ProFlex CO2 Laser Fiber | |
| K number | K203799 | ||
| Product code | GEX | ||
| Indications for use | Single Use CO2 Laser Fiber is | ||
| indicated for the ablation, | |||
| coagulation, excision, incision, and | |||
| vaporization of soft tissue in open, | |||
| endoscopic, and laparoscopic | |||
| surgical procedures. | |||
| Indications involving heart or | |||
| central circulatory system, or the | |||
| central nervous system are | |||
| excluded from optical fibers | |||
| intended use. | ProFlex CO2 Laser Fiber is | ||
| indicated for the ablation, | |||
| coagulation, excision, incision, | |||
| and vaporization of soft tissue in | |||
| open, endoscopic, and | |||
| laparoscopic surgical procedures. | Same general indications (i.e. | ||
| ablation, coagulation etc.) with | |||
| the difference that we have | |||
| excluded heart, central | |||
| circulatory system and central | |||
| nervous system from the | |||
| intended use as, according to | |||
| EU regulation 2017/745, a | |||
| contact to these tissues would | |||
| affect device risk classification | |||
| (class III instead of IIa). | |||
| The device keeps the same | |||
| labelling and instructions for | |||
| use for both US and EU (CE | |||
| mark). | |||
| Compatible laser | |||
| wavelength | |||
| (μm) | 10.6 (CO2) | 10.6 (CO2) | The same |
| Maximum input | |||
| power (W) | 40 | 40 | The same. |
| Maximum input power has | |||
| been verified with performance | |||
| test report BRE20240109RD | |||
| attached in e-star section | |||
| "Performance testing". | |||
| Power transmission | |||
| (%) | 60-70 | ≥60% | The minimum transmission |
| power is the same. | |||
| Transmission has been | |||
| characterized in performance | |||
| report BRE20240109RD | |||
| attached in e-star section | |||
| "Performance testing". | |||
| Bending radius | 4 cm at 120° | With power 0-30 W: 4 cm @90° | |
| With power 30-40W: 4 cm @45° | Similar. Verified in | ||
| performance report | |||
| BRE20240109RD attached in e- | |||
| star section "Performance | |||
| testing". | |||
| Lumen diameter D1 | |||
| (μm) | 500 | 500 | The same |
| Outer diameter D3 | |||
| (µm) | 1040 | 1040 | The same |
| Fiber length (m) | 2 | 2 | The same |
| Materials | A: ETFE (Tefzel) | ||
| B: Fused silica | |||
| C: Silver | |||
| D: Silver iodide | A: ETFE (Tefzel) | ||
| X: Fluoropolymer | |||
| B: Fused silica | |||
| C: Silver | The predicate device has an | ||
| additional layer (fluoropolymer | |||
| cladding). | |||
| Subject device | Predicate device | Equivalence rationale | |
| Model n° | Single Use CO2 laser fiber | ProFlex CO2 Laser Fiber | |
| K number | K203799 | ||
| D: Silver iodide | Cladding usually has the only | ||
| function to enhance fiber | |||
| mechanical properties. The | |||
| absence of this layer in the | |||
| subject device doesn't affect | |||
| safety and performance. | |||
| Connector type | SMA905 | Stainless steel connector (e.g. | The same |
| SMA905) | |||
| Number of uses | ਹ | । | The same |
| Packaging | Polypropylene holder | HDPE tubular carrier | Packaging has been validated |
| Double pouch made of: | Pouch made of non- | for a 5 years shelf life after | |
| Plastic film (PET/PP) |
-
| woven/impermeable polymer | accelerated ageing (see e-star |
| | Medical grade paper
-
| (e.g. Tyvek/Mylar) | section "Reprocessing, Sterility, |
| | | | and Shelf-Life"). |
| Sterilization | EtO | EtO | The same |
| method | | | |
| Shelf life | 5 years | 3 years | Shelf life has been validated by |
| | | | accelerated ageing on fiber |
| | | | packaging (see e-star section |
| | | | "Reprocessing, Sterility, and |
| | | | Shelf-Life") |
Table 3: Substantial equivalence comparison table.
8
5 Non-clinical tests
The present device was subject to non-clinical bench testing according to the following standards:
Table 4: Non-clinical tests summary.
| Standard | Discussion | e-star section |
|---|---|---|
| ISO 10993-1: 2018 | The following tests have been | Refer to e-star section |
| Biological evaluation of medical devices. | performed with positive results: | "Biocompatibility". |
| Part 1: Evaluation and testing within a risk | - | |
| Cytotoxicity | ||
| management process. | - | |
| Sensitization | ||
| - | ||
| Irritation | ||
| Acute systemic toxicity |
-
| |
| | Pyrogenicity
-
| |
| ISO 11607-1: 2019 | Device packaging has been assessed | Refer to e-star section "Reprocessing, |
| Packaging for terminally sterilized medical | after accelerated ageing (to simulate 5 | Sterility, and Shelf-Life". |
| devices. | years shelf life). | |
| Part 1: Requirements for materials, sterile | | |
| barrier systems and packaging systems. | | |
| ISO 11607-2: 2019 | | |
| Packaging for terminally sterilized medical | | |
| devices. | | |
| Part 2: Validation requirements for forming, | | |
| sealing and assembly processes | | |
| ISO 11135: 2014 | EtO sterilization validation has been | Refer to e-star section "Reprocessing, |
| Sterilization of health-care products. | performed for both sterilization sites | Sterility, and Shelf-Life". |
| Ethylene oxide. | (Steril Verona and Steris). | |
| Requirements for the development, | | |
| validation and routine control of a | | |
| sterilization process for medical devices | | |
| Performance (laser transmission and | It has been verified that laser | Refer to e-star section "Performance |
| minimum bending radius) | transmission is within 60 and 70% in | testing". |
| | both normal conditions and with the | |
| | fiber bent at the minimum bending | |
| | radius at both 25 and 40W. | |
9
The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively.
Substantial equivalence discussion б
Single Use CO2 laser fiber has comparable indications for use of the predicate device and equivalent technological characteristics as shown in Table 3. Moreover, non-clinical tests conducted (Table 4) support that the device can be used safely and effectively.
Conclusions 7
Based on the comparison and the non-clinical tests, the substantially equivalent to the predicate device.