(27 days)
Litho DK30 (K141403)
Not Found
No
The summary describes a laser system for surgical procedures and lithotripsy. It details modifications to housing and the graphic user interface but explicitly states the device has the "same components, the same laser source emission specifications and the same controlling principles" as the predicate device. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is indicated for surgical procedures like incision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue, and Lithotripsy of stones, which are therapeutic interventions. Additionally, one of the consensus standards it adheres to is for "Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment," explicitly mentioning 'Therapeutic'.
No
Explanation: The device is indicated for surgical procedures like incision, resection, ablation, vaporization, coagulation, hemostasis, and lithotripsy of stones. These are therapeutic, not diagnostic, actions.
No
The device description explicitly states it is a "laser system, including a fiber optic delivery system" and mentions "housing of components: tower frame instead of desktop". This indicates it is a hardware device with physical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for procedures like incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, and lithotripsy of stones. These are all direct surgical interventions on the body.
- Device Description: The device is described as a Pulsed Holmium:YAG laser with a fiber optic delivery system. This is a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to provide information about a person's health status.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used for treatment.
N/A
Intended Use / Indications for Use
The MH01 laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
It is indicated in medical specialties including, but not limited to:
- · Urology
- · Gastroenterology
- Arthroscopy
- Neurosurgery
- Pulmonary
- Gynecology
- · ENT
- · Dermatology
- · Plastic Surgery
- · General Surgery
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
This Special 510(k) of the modified device MH01 is submitted due to Device Modifications of the already cleared device Litho DK30 (K141403Q): MH01 differs from Litho DK30 (K141403Q) about: - housing of components: tower frame instead of desktop
- graphic user interface
The modified device MH01 has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
The modified and unmodified devices have the same components, the same laser source emission specifications and the same controlling principles.
Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um.
There are not incremental changes from the original clearance K141403Q to be taken into account other than the differences between modified and unmodified devices.
The modified device MH01 shares the same architecture and the same laser source of the unmodified device Litho DK30: both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 µm, with no change in the fundamental scientific technology of the device.
The modified device MH01 has the same intended use of the unmodified device. Moreover the intended use of the modified device, as described in its labelling, has not changed as a result of the modifications.
The following modifications have been implemented on the cleared device Litho DK30 (K141403) in order to get the tower version named MH01:
- A new mechanical structure housing the internal components, and related covers have been developed
- The GUI (Graphic User Interface) has been reviewed
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, stones
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)
The modified device MH01 was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:
- IEC 60601-1:2005, Mod - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- IEC 60601-2-22 Third Edition 2007-05, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
- IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
The modified device MH01 passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.
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.
Litho DK30 (K141403)
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing line that forms a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Quanta System SPA Mr. Francesco Dell'Antonio Compliance Manager Via IV Novembre, 116 21058 Solbiate Olana (Va) Italy
September 3, 2015
Re: K15220 Trade/Device Name: MH01 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: July 23, 2015 Received: August 7, 2015
Dear Mr. Dell'Antonio:
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. 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.
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
For
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K15220
Device Name MH01
Indications for Use (Describe)
The MH01 laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
It is indicated in medical specialties including, but not limited to:
- · Urology
- · Gastroenterology
- Arthroscopy
- Neurosurgery
- Pulmonary
- Gynecology
- · ENT
- · Dermatology
- · Plastic Surgery
- · General Surgery
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5. Special 510(K) SUMMARY - Device Modifications
Introduction:
This document contains the 510(k) Summary for the device MH01. The basis of this submission is Modifications to Device already cleared. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant /
Manufacturer
Name and Address: | Quanta System SPA
Via IV Novembre, 116
Solbiate Olona (VA)
Italy, 21058 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio
Compliance Manager
Quanta System SPA |
| | Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +39-0331-367815 |
| Date Prepared: | July 23th, 2015 |
| Device Name: | MH01 |
| 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 |
| Basis for Submission: | Device modifications |
| Legally Marketed Device | Litho DK30 (K141403) – Quanta System SPA |
The modified device MH01 is claimed to be derived from the legally marketed (unmodified) device Litho DK30 (K141403) because MH01 is the tower version of the already cleared device Litho DK30 (K141403) with modified graphic user interface.
Performance Standards:
This device complies with 21 CFR 1040.10 and 1040.11.
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General Device Description:
This Special 510(k) of the modified device MH01 is submitted due to Device Modifications of the already cleared device Litho DK30 (K141403Q): MH01 differs from Litho DK30 (K141403Q) about: - housing of components: tower frame instead of desktop
- graphic user interface
The modified device MH01 has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
The modified and unmodified devices have the same components, the same laser source emission specifications and the same controlling principles.
Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um.
There are not incremental changes from the original clearance K141403Q to be taken into account other than the differences between modified and unmodified devices.
Description of the modifications:
The modified device MH01 shares the same architecture and the same laser source of the unmodified device Litho DK30: both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 µm, with no change in the fundamental scientific technology of the device.
The modified device MH01 has the same intended use of the unmodified device. Moreover the intended use of the modified device, as described in its labelling, has not changed as a result of the modifications.
The following modifications have been implemented on the cleared device Litho DK30 (K141403) in order to get the tower version named MH01:
- A new mechanical structure housing the internal components, and related covers have been developed
- । The GUI (Graphic User Interface) has been reviewed
Based on the nature of the changes implemented, the device underwent and successfully passed EMC, electrical safety and performance testing according to IEC 60601-1 and its collateral standards.
Picture 7-1 shows the external appearance of the modified device and the unmodified device.
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Image /page/6/Picture/1 description: The image contains two medical devices. The device on the left is a black and silver box with a screen that displays various settings and parameters. The device on the right is a white machine with a screen on top and a large pink "R" logo on the side. Both devices appear to be used for medical treatments or procedures.
Picture 5-1 – device Litho DK30 (on the left) and MH01 (on the right)
Intended Use/Indications for Use
The modified device MH01 has the same intended use of the unmodified device, as follows:
The MH01 laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
lt is indicated in medical specialties including, but not limited to:
- Urology
- Gastroenterology
- Arthroscopy
- Neurosurgery
- Pulmonary
- Gynecology
- ENT
- Dermatology
- . Plastic Surgery
- General Surgery
Moreover the intended use of the modified device, as described in its labelling, has not changed as a result of the modifications.
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Substantial Equivalence:
The modified and unmodified devices have the same components, the same laser sources with the same emission specifications and the same controlling principles.
The modified device MH01 has the same intended use of the unmodified device.
Thus the modified device MH01 is substantially equivalent to the previously leqally marketed device Litho DK30 (K141403).
Performace testing
The modified device MH01 was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:
- -IEC 60601-1:2005, Mod - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- -IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- -IEC 60601-2-22 Third Edition 2007-05, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
- -IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
The modified device MH01 passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.