(65 days)
Not Found
No
The description focuses on the laser technology and its physical properties, with no mention of AI or ML capabilities in the device description, intended use, or specific sections for AI/ML information.
Yes
The device is intended for use in surgical procedures to break up stones, cut tissue, and perform other therapeutic actions, which indicates it is a therapeutic device.
No
The device description indicates its use in surgical procedures for breaking up stones, cutting, ablation, vaporization, excision, incision, and coagulation of tissue, which are all therapeutic actions, not diagnostic.
No
The device description explicitly lists hardware components such as a Laser Unit, fiber port, microprocessor control electronics, and a footswitch, in addition to operating software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device being used in surgical procedures on the patient's body (breaking up stones, cutting tissue, etc.). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The description details a laser system designed for surgical intervention, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a surgical laser system used for therapeutic purposes directly on the patient.
N/A
Intended Use / Indications for Use
The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery.
Product codes
GEX
Device Description
The ACMI® DUR-HL Laser Systems are pulsed solid-state Holmium YAG Lasers with a wavelength of approximately 2080 nm (2.1um). This wavelength is absorbed primarily by water, whereby an average penetration depth of approx. 400 um (0.4 mm). The lasers are Class IV lasers pursuant to 21CFR 1040 and designed to comply with the requirements outlined in 21 CFR 1040. The ACMI® DUR-HL Laser Systems are comprised of the following components:
- Laser Unit, which includes Laser console, control and display panel .
- . Fiber port for delivery systems
- System microprocessor control electronics .
- Covered footswitch .
- . Operating software
- (For use with) a variety of fiber optic delivery devices/accessories. .
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)
Reference Device(s)
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
ACMI® DUR-HL Laser Systems ACMI Corporation 136 Turnpike Road Southborough, MA 01772
510(k) Notification
K 060752
510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® DUR-HL Laser Systems
MAY 2 5 2006
General Information
Manufacturer: ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104 Contact Person: Lorraine Calzetta Regulatory Affairs Tel. #: 508-804-2752 Fax #: 508-804-2624 Date Prepared: March 16, 2006 Device Description Classification Name: Class II ( 21 CR 878. 4810)
Laser surgical instrument for use in general and plastic surgery and in dermatology
ACMI® DUR-HL Laser Systems
Laser, Holmium YAG, Surgical
Trade Name:
Generic/Common Name:
Predicate Devices
WaveLight Auriga Laser Dornier Medilas H Laser Systems
Intended Uses
The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecol ogy, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery.
14
1
Product Description
The ACMI® DUR-HL Laser Systems are pulsed solid-state Holmium YAG Lasers with a wavelength of approximately 2080 nm (2.1um). This wavelength is absorbed primarily by water, whereby an average penetration depth of approx. 400 um (0.4 mm). The lasers are Class IV lasers pursuant to 21CFR 1040 and designed to comply with the requirements outlined in 21 CFR 1040. The ACMI® DUR-HL Laser Systems are comprised of the following components:
- Laser Unit, which includes Laser console, control and display panel .
- . Fiber port for delivery systems
- System microprocessor control electronics .
- Covered footswitch .
- . Operating software
- (For use with) a variety of fiber optic delivery devices/accessories. .
Technological Characteristics and Substantial Equivalence
The ACMI® DUR-HL Laser Systems utilize features such as indications for use, design, materials, technological characteristics, and operational characteristics incorporated into the following legally marketed predicate devices:
WaveLight Auriga cleared under K051399 Dornier Medilas H Laser Systems cleared under K983963
In summary, the ACMI® DUR-HL Laser Systems are substantially equivalent to the predicate devices and present no new questions of safety or efficacy.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
ACMI Corporation. % Ms. Lorraine Calzetta Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104
Re: K060752
Trade/Device Name: ACMI® DUR-HL Laser Systems 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: March 16, 2006 Received: March 21, 2006
Dear Ms. Calzetta:
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. Lorraine Calzetta
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Notification
ACMI® DUR-HL Laser Systems ACMI Corporation 136 Turnpike Road Southborough, MA 01772
Device Name: ACMI® DUR-HL Laser Systems
510(k) Number: K060752
Indications for use:
The ACMI® DUR-HL Laser Systems are intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (for example, strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (for example, DCR), Lithotripsy, Orthopedics, Discectorny and General Surgery
_ Prescription Use: __ X
OR Over-the-Counter Use: _
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q.mQ
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number. Koso752
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