(27 days)
Not Found
No
The device description and intended use focus solely on the physical components and function of laser delivery fibers, with no mention of AI or ML capabilities.
Yes
The device is indicated for medical procedures such as incision/excision, ablation, and coagulation across various surgical specialties, which are therapeutic actions.
No
The device is indicated for incision, excision, ablation, and coagulation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical components such as glass fiber optics, sheaths, SMA connectors, handles, and stainless steel needles/cannulas, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The Accutech Family of PowerFlex laser delivery devices are used for surgical procedures performed directly on the patient's body (incision, excision, ablation, coagulation). They deliver laser energy to various anatomical sites.
The device is a surgical tool used in vivo (within the living body), not for in vitro testing of specimens.
N/A
Intended Use / Indications for Use
The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Accutech Family of PowerFlex Laser Delivery Devices is comprised of the following main components (by fiber optic configuration type):
Bare Fibers - No Sheaths
- Glass fiber optic with jacket .
- . SMA connector
Bare Fibers - With Sheaths
- Glass fiber optic with jacket .
- Sheath .
- SMA connector .
SideFire Fibers
- Glass fiber optic with jacket with distal (patient contact) fiber tip encased in . glass capillary tube
- SMA connector .
- Adjustable handle (tightens on fiber to allow user to direct laser energy to desired target site)
Endoprobes/ ENT Fibers
- A glass fiber optic protected by a medical grade stainless steel needle/ cannula (patient contact) and handle at the distal end and by a plastic jacket from the proximal to distal end
- SMA connector .
Additional Accessory(ies)
- Optional Radiofrequency identification (RF ID) connector for use with INTERmedic Diode Laser Family of lasers (as specified to Accutech Medical by INTERmedic for use with their laser systems)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
K061025, K073496, K050738, K013300
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
Section 5 - 510(k) Summary or 510(k) Statement
I. General Information
Submitter:
Accutech Medical Technologies, Inc. 125 Fleming Drive Cambridge, Ontario NIT 2B8 Canada
Contact Person:
Gregory Berzak Regulatory Affairs Officer Tel: 519-620-3900, ext. 1901
Summary Preparation Date: February 4. 2009
II. Names
Device Names: Accutech Family of PowerFlex Laser Delivery Devices
Primary Classification Names: Accessory for, Laser Powered Surgical Instruments
III. Predicate Devices
- . Accutech EndoLite Probe (K061025)
- Cook Urological OptiLite™ Holmium Laser Fibers (K073496); .
- FiberTech (FT) Fiber Optic Delivery Systems (K050738); .
- Technology Delivery Systems MaxiFlex Fiberoptic Energy Delivery System . (K013300)
IV. Product Description
The Accutech Family of PowerFlex Laser Delivery Devices is comprised of the following main components (by fiber optic configuration type):
Bare Fibers - No Sheaths
- Glass fiber optic with jacket .
- . SMA connector
Bare Fibers - With Sheaths
- Glass fiber optic with jacket .
- Sheath .
- SMA connector .
SideFire Fibers
- Glass fiber optic with jacket with distal (patient contact) fiber tip encased in . glass capillary tube
- SMA connector .
- Adjustable handle (tightens on fiber to allow user to direct laser energy to � desired target site)
Page 1 of 2
1
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Endoprobes/ ENT Fibers
- A glass fiber optic protected by a medical grade stainless steel needle/ cannula ● (patient contact) and handle at the distal end and by a plastic jacket from the proximal to distal end
- SMA connector .
Additional Accessory(ies)
- Optional Radiofrequency identification (RF ID) connector for use with ● INTERmedic Diode Laser Family of lasers (as specified to Accutech Medical by INTERmedic for use with their laser systems)
V. Indications for Use
The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision/ excision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.
VI. Rationale for Substantial Equivalence
The Accutech Family of PowerFlex Laser Delivery Devices shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Accutech Family of PowerFlex Laser Delivery Devices is substantially equivalent to the predicate devices.
VIII. Conclusion
The Accutech Family of PowerFlex Laser Delivery Devices was found to be substantially equivalent to the predicate devices.
The Accutech Family of PowerFlex Laser Delivery Devices shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
0016
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 2009
Accutech Medical Technologies, Inc. % A L Voss Associates Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566
Re: K090281
Trade/Device Name: Accutech Family of PowerFlex Laser Delivery Devices Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 4, 2009 Received: February 5. 2009
Dear Ms. Worden:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Anne Worden
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmaties surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmaner, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
f ti mid. for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K090 2281 510(k) Number (if known):
Device Name: Accutech Family of PowerFlex Laser Delivery Devices
Indications for Use:
The Accutech Family of PowerFlex laser delivery devices (bare fibers, sidefire fibers, ENT fibers, and Endoprobes) are indicated for incision, ablation, and coagulation (hemostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode and Ho:YAG wavelengths (488 - 2100 nm) for the indications for which the lasers have been cleared, including: general and cosmetic surgery, intraoral soft-tissue, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery.
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Oyler Forman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K090228
0014