(266 days)
Not Found
No
The description focuses on the physical components and materials of a laser fiber for surgical procedures. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is a therapeutic device because its intended use includes "ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures," which are therapeutic actions.
No
The device is described as an energy delivery device used for ablation, coagulation, incision, and vaporization of soft tissue in surgical procedures, not for diagnosing conditions.
No
The device description clearly outlines physical components like a stainless steel connector, glass tube, and protective jacket, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures." This describes a device used directly on the patient's body during surgery.
- Device Description: The description details a fiber optic energy delivery device designed to transmit laser energy for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used in a laboratory setting or point-of-care setting to analyze biological samples. This device is clearly intended for use in vivo (within the living body) during surgical interventions.
N/A
Intended Use / Indications for Use
ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
Product codes
GEX
Device Description
ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket.
ProFlex CO2 Laser Fibers are packaged in a coiled and tubular, high-density polyethylene (HDPE) carrier providing improved ease of dispensing within the surgical field while maintaining sterility. Coils are contained within non-woven/impermeable polymer, e.g. Tyvek/Mylar, sterile pouches, validated for three-year shelf life, and protected with an outer, nonsterile fiberboard carton. Both sterile pouch and carton are labeled.
All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO) sterilization.
ProFlex CO2 Laser Fibers are for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open, endoscopic, and laparoscopic surgical procedures.
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 were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
- Bench Testing to support labeling and verify the performance (e.g., ProFlex CO2 Laser Fiber Instructions for use and labels, Fiber Design Verification, Packaging Design Verification)
- Performance Qualification of ProFlex CO2 with Hoop Insert Packaging to Demonstrate 10t6 Sterility per ISO 11135:2014 and Ethylene Oxide sterilization residuals per ISO 10993-7:2008
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
September 20, 2021
InnovaQuartz LLC Stephen Griffin Chief Technology Officer 23030 N. 15th Ave Phoenix, Arizona 85027
Re: K203799
Trade/Device Name: ProFlex CO2 Laser Fiber (Model: S-COF500) 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: August 18, 2021 Received: August 20, 2021
Dear Stephen Griffin:
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.
1
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 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 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-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.
Purva U. Pandya -S
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203799
Device Name ProFlex CO2 Laser Fiber (Model: S-COF500)
Indications for Use (Describe)
ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
The assigned 510(k) Number: K203799
| 1. Date of Preparation | 09/17/2021 |
|---|---|
| ------------------------ | ------------ |
| 2. Applicant | |
|---|---|
| Name: | InnovaQuartz, LLC. |
| Address: | 23030 N 15th Ave, Phoenix, AZ 85027-1315 |
| Phone: | 623-434-1895 |
| Registration #: | 3010933841 |
|---|---|
| ----------------- | ------------ |
| Contact Person: | Stephen Griffin, CTO |
|---|---|
| Telephone: | 623-434-1895 (main) x101, 623-229-5174 (mobile) |
| Email: | steveg@innovaquartz.com |
-
- Identification of the Proposed Device
| Trade Name: | ProFlex CO2 Laser Fiber |
|---|---|
| Common Name: | Laser Fiber |
| Model(s): | S-COF500 |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification: | II |
| Product Code: | GEX |
| Regulation Number: | 21 CFR 878.4810 |
| Review Panel: | General & Plastic Surgery |
- Identification of Predicate Device 4.
| 510(k) Number: | K100384 |
|---|---|
| Product Name: | CO2 Laser WaveGuide |
| Manufacturer: | Lumenis Ltd., 13 Hayetzira St. (POB 240), Yokneam Industrial Park Yokneam, 20692 Israel |
-
- Device Description
ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket.
- Device Description
ProFlex CO2 Laser Fibers are packaged in a coiled and tubular, high-density polyethylene (HDPE) carrier providing improved ease of dispensing within the surgical field while maintaining sterility. Coils are contained within non-woven/impermeable polymer, e.g. Tyvek/Mylar, sterile pouches, validated for three-year shelf life, and protected with an outer, nonsterile fiberboard carton. Both sterile pouch and carton are labeled.
All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO) sterilization.
ProFlex CO2 Laser Fibers are for prescription use only.
-
- Indications for Use
ProFlex CO2 Laser Fiber is indicated for the ablation, excision, incision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
- Indications for Use
4
7. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device K161926 | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| 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. | The fiberlase CO2 laser waveguide is | ||
| intended for use in surgical procedures | |||
| requiring ablation, vaporization, excision, | |||
| incision and coagulation of soft tissue. The | |||
| fiberlase CO2 laser waveguide is indicated | |||
| for use in open surgical procedures such as | |||
| ent surgery and laparoscopy and endoscopic | |||
| procedures. The device is limited to carbon | |||
| dioxide lasers having a sma-905 connector. | SE |
Tab 1 General Comparison
The technical characteristics of the subject and predicate devices are compared in the table below.
| Device & Predicate Device(s): | K203799
(Subject Device) | K100384
(Primary Predicate) |
|----------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| General Device Characteristics | | |
| Laser Type and wavelength (nm) | CO2, 10600 | CO2, 10600 |
| Inner diameter (µm) | 500 | 500 |
| Outer diameter (µm) | 1040 | 1040 |
| Length (m) | 2 | 2 |
| Maximum Input Power (W, CW) | 40 | 40 |
| Maximum Input Power (W, super-pulse
mode) | 15 | 15 |
| Operative Bending | 40mm radius @ 45°, 40 W
40mm radius @ 90°, 30 W | 40mm radius @ 45°, 40 W
40mm radius @ 90°, 30 W |
| Transmission Efficiency (Loss) | ≥ 60% ( 60% ( Bench Testing to support labeling and verify the performance (e.g., ProFlex CO2 Laser Fiber Instructions for use and labels, Fiber Design Verification, Packaging Design Verification)
-
Performance Qualification of ProFlex CO2 with Hoop Insert Packaging to Demonstrate 10t6 Sterility per ISO 11135:2014 and Ethylene Oxide sterilization residuals per ISO 10993-7:2008
9. Clinical Testing
No clinical study is included in this submission.
-
- Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.
- Conclusion