(68 days)
Not Found
No
The description focuses on the physical characteristics and function of a laser fiber accessory, with no mention of AI or ML capabilities.
Yes
The device is described as being used for medical procedures like incision, vaporization, ablation, and coagulation of soft tissue, which are therapeutic actions. It is also an accessory to a medical laser, indicating its role in treatment.
No
Explanation: The InnoVoyce Laser Fiber is intended for use in surgical procedures (incision, vaporization, ablation, and coagulation of soft tissue) by delivering laser energy. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a physical laser fiber made of glass and other materials, designed to deliver laser energy. It is a hardware component used as an accessory to a laser system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "incision, vaporization, ablation, and coagulation of soft tissue." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a laser fiber designed to deliver laser energy for surgical purposes. It's an accessory to a surgical laser system.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue samples, etc.) outside of the body to provide information about a patient's health. IVDs are specifically designed for testing samples in vitro (in glass or in a lab setting).
Therefore, the InnoVoyce Laser Fiber is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
InnoVoyce Laser Fiber is intended for use in incision/excision, vaporization, ablation, and coagulation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser. They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers. The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer.
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
surgeon and a laser safety officer
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 Performance Testing: Non-clinical testing was performed on InnoVoyce Laser Fiber, (the subject device) and demonstrates compliance with the following International and FDA-recognized consensus standards:
- ISO 14971:2007 Medical devices Application of risk management to medical devices .
- ISO-10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and ● skin sensitization
- . ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . USP - MEDICAL DEVICES-BACTERIAL ENDOTOXIN AND PYROGEN TESTS
- . ISO 11135:2014/Amd.1:2018 - Sterilization of health-care products-Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release
- . ISO 11138-2:2017 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11737-1:2018 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- . ISO 11607-1:2019 - Packaging for terminally sterilized medical devices – 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.
The subject device was tested in accordance with Verification and Validation processes in accordance with design control practices. Testing has been performed to address intended use, the technological characteristics, requirement specifications, and the risk management results.
Clinical Data: No clinical testing was required to demonstrate safety or effectiveness for the subject device as the device's non-clinical (bench) testing was sufficient to support the intended use of the device.
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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
May 25, 2022
InnoVoyce LLC % Cori Ragan Principal Advisor, Regulatory and Quality System Labcorp 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334
Re: K220793
Trade/Device Name: InnoVoyce Laser Fiber 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: March 16, 2022 Received: March 18, 2022
Dear Cori Ragan:
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 Pandya, D.Eng. 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
2
Indications for Use
510(k) Number (if known) K220793
Device Name InnoVoyce Laser Fiber
Indications for Use (Describe)
Inno Voyce Laser Fiber is intended for use in incision, vaporization, ablation, and coagulation of soft tissue.
| 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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3
5.0 TRADITIONAL 510(K) SUMMARY
I. Submitter Information
| Submitted by: | Labcorp |
|---|---|
| Contact Person: | Cori Ragan |
| Principal Advisor | |
| Labcorp | |
| 5353 Wayzata Boulevard, Suite 505 | |
| Minneapolis, Minnesota 55416 | |
| Telephone: 612-268-8746 | |
| Cori.Ragan@labcorp.com | |
| Date of Summary: | May 23, 2022 |
II. Device Information
| Device Trade Name: | InnoVoyce Laser Fiber |
|---|---|
| Common or Usual Name: | Surgical laser instrument |
| Classification Name: | 878.4810 - Laser surgical instrument for use in general and plastic |
| surgery and in dermatology. | |
| Class: | 2 |
| Product Code: | GEX |
| Review Panel: | General & Plastic Surgery |
| Model Number: | S-00102-300, S-00103-400, S-00104-600 |
lll. Predicate Information
| Predicate Information | |
|---|---|
| Predicate Device: | LISA Laser Surgical Fiber |
| Company: | Omni-Guide Holding, Inc. |
| 510(k) Number: | K220189 |
| Common or Usual Name: | Surgical laser instrument |
| Classification Name: | 878.4810 - Laser surgical instrument for use in general and plastic |
| surgery and in dermatology. | |
| Class: | 2 |
| Product Code: | GEX |
| Review Panel: | General & Plastic Surgery |
IV. Device Description
The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser.
They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers.
The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer.
4
V. Indication for Use
InnoVoyce Laser Fiber is intended for use in incision/excision, vaporization, ablation, and coagulation of soft tissue.
Substantial Equivalence VI.
A comparison of the technological characteristics of the predicate and subject device is given in Table 5-1 below:
| Device | Subject Device –
InnoVoyce Laser
Fiber | Predicate Device –
LISA Laser Surgical
Fibers (K220189) | Equivalence |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Indications or
intended use | InnoVoyce Laser
Fiber is intended for
use in
incision/excision,
vaporization,
ablation, and
coagulation of soft
tissue. | Omni-Guide Holdings,
Inc. single-use LISA
Laser Surgical Fibers
are indicated for use in
all surgical specialties in
which compatible laser
systems with operational
wavelengths between
500nm - 2200nm have
received regulatory
clearance.
Omni-Guide Holdings,
Inc. single-use LISA
Laser Surgical Fibers
devices are intended for
use with any cleared
surgical
laser with an SMA 905
connector, SMA 906
connector, or
manufacturer specific
connectors and
adapters. | Similar/Equivalent |
| Product Code | GEX | GEX | Same |
| Classification
Name | 878.4810 - Laser
surgical instrument
for use in general
and plastic surgery
and in dermatology. | 878.4810 - Laser
surgical instrument for
use in general and
plastic surgery and in
dermatology. | Same |
| Classification | Class II | Class II | Same |
| Use of Device | Rx Only | Rx Only | Same |
| Laser Source | Aura XP surgical
laser console | Use with any cleared
surgical laser with an
SMA 905 connector,
SMA 906 connector, or
manufacturer specific
connectors and
adapters. | Different.
No new or increase risk
and no impact to safety
and effectiveness when
used with applicable laser
source. |
| Table 5-1: Substantial Equivalence | |
|---|---|
5
| Connectors | Proprietary | SMA 905 and SMA 906 | Different.
No new or increase risk
and equivalent safety and
effectiveness when used
with a compatible laser
system containing an
applicable connector. |
|-------------------------|----------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Wavelength | 532 nm | 532nm–2100nm | Same (within range of
predicate) |
| Maximum
Power | 15W | 1-300 Watts | Same (within range of
predicate) |
| Fiber Sizes | 300, 400, and 600
microns | Fibers are offered in a
range of sizes suitable to
user needs | Similar/Equivalent |
| Outer
Diameter | 300 = 1.2 Fr
400 = 1.7 Fr
600 = 2.3 Fr | Core diameters are
offered in a range of
sizes suitable to user
needs | Similar/Equivalent |
| Fiber Core
Material | Silica Glass | Fused Silica | Similar/Equivalent |
| Jacket
Material | ETFE | Nylon, Polyimide, or
Teflon | Similar/Equivalent |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization
method | EO | EO | Same |
6
VII. Performance Data
Non-Clinical Performance Testing:
Non-clinical testing was performed on InnoVoyce Laser Fiber, (the subject device) and demonstrates compliance with the following International and FDA-recognized consensus standards:
- ISO 14971:2007 Medical devices Application of risk management to medical devices .
- ISO-10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and ● skin sensitization
- . ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . USP - MEDICAL DEVICES-BACTERIAL ENDOTOXIN AND PYROGEN TESTS
- . ISO 11135:2014/Amd.1:2018 - Sterilization of health-care products-Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release
- . ISO 11138-2:2017 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11737-1:2018 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- . ISO 11607-1:2019 - Packaging for terminally sterilized medical devices – 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.
The subject device was tested in accordance with Verification and Validation processes in accordance with design control practices. Testing has been performed to address intended use, the technological characteristics, requirement specifications, and the risk management results.
Clinical Data:
No clinical testing was required to demonstrate safety or effectiveness for the subject device as the device's non-clinical (bench) testing was sufficient to support the intended use of the device.
VIII. Conclusion
The InnoVoyce single-use optical fibers that are the subject of this premarket notification use identical or similar technology as that of the single-use fibers of the K220189 510(k). Differences between the proposed and predicate fibers do not raise new types of concerns for safety and effectiveness, and performance testing demonstrates that the InnoVoyce single-use optical fibers can be used safely and effectively for the proposed indications for use. The InnoVoyce single-use optical fibers are considered to be substantially equivalent to the predicate K220189.