(71 days)
No
The document describes a laser surgical instrument and does not mention any AI or ML capabilities.
Yes
The device is used to perform surgical procedures like incision, resection, ablation, vaporization, coagulation, hemostasis, and lithotripsy of stones, all of which aretherapeutic interventions.
No
The device is described as a surgical instrument for performing procedures like incision, resection, ablation, and lithotripsy, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "Laser surgical instrument" and includes a "fiber optic delivery system," indicating it is a hardware device with physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The intended use and indications clearly describe a surgical laser used for procedures on the body (incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, and lithotripsy of stones). This is an in vivo application.
- Device Description: The device is described as a "Laser surgical instrument." This further reinforces its use in surgical procedures on living tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
Therefore, the Litho DK30 is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device Litho DK30 including a fiber optic delivery system is intended to be used 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.
The device Litho DK30 including a fiber optic delivery system is insurgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to:
- Urology
- · Gastroenterology
- Arthroscopy
- Neurosurgery
- Pulmonary
- Gynecology
- ENT
- Dermatology
- Plastic Surgery
- General Surgery
Product codes
GEX
Device Description
The modified device Litho DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909): Litho DK30 is the desktop version of the already cleared device Litho (K09109). The modified device Litho DK30 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. Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um.
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
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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7. Special 510(K) SUMMARY - Device Modifications
Introduction:
This document contains the 510(k) Summary for the device Litho DK30. 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: | Maurizio Bianchi
Regulatory Affairs Manager
Quanta System SPA |
| | Email: maurizio.bianchi@quantasystem.com
Phone: +39 0331 376797
Fax: +39 0331 367815 |
| Date Prepared: | May 24th, 2014 |
| Device Name: | Litho DK30 |
| 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 (K091909) |
The modified device Litho DK30 is claimed to be derived from the legally marketed (unmodified) device Litho (K091909) because Litho DK30 is the desktop version of the already cleared device Litho (K09109).
Performance Standards:
There are no mandatory performance standards for this device.
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General Device Description:
The modified device Litho DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX).
This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909): Litho DK30 is the desktop version of the already cleared device Litho (K09109).
The modified device Litho DK30 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.
Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um.
The sum of the incremental changes from the original clearance K091009 has been taken into account and all the occurred modifications will be listed and described within this submission.
The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to: Urology, Gastroenterology, Arthroscopy, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The modified device Litho DK30 is claimed to be derived from the legally marketed (unmodified) device Litho (K091909) because Litho DK30 is the desktop version of the already cleared device Litho (K09109).
Description of the modifications:
The modified device Litho DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX).
This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909) because Litho DK30 is the desktop version of the already cleared device Litho (K09109).
The modified device Litho DK30 share the same architecture and the same laser source of the unmodified device Litho: 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 Litho DK30 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.
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The following modifications have been implemented on the cleared device Litho (K091909) in order to get the desktop version named Litho DK30:
- A new mechanical structure and related covers have been developed
- A more compact and lightweight power-supply with extended working range has been qualified.
- The water pump of the cooling systern has been changed to improve the cooling efficiency. -
- The water-to-air heat-exchanger has been changed to improve the cooling efficiency.
- i The technical specifications of lens focusing the laser beam into the optical fiber has been changed to improve the incoupling.
- An RFID recognition system has been added to read the fiber diameter directly from the n fiber equipped with the suitable transponder.
- Review of the combinations of the laser parameters (energy and frequency) achievable within 30 W maximum power.
- A larger touch-screen has been adopted
- The control hardware (boards) and related software have been reviewed
- The GUI (Graphic User Interface) has been reviewed to improve the readability i
All the modifications implemented have been evaluated following the requirements of third edition of IEC 60601-1 and to its collateral standards. The introduction of the third edition of the IEC 60601-1 and to its collateral standards has been taken into account: it leaded to a basic change in the (regulatory) design input requirements with the subsequent revision of risk analysis and specific verification and validation activities to demonstrate that modified device meet the new requirements.
Picture 7-1 shows the the external appearance of the modified device and the unmodified device.
Image /page/2/Picture/13 description: The image contains two medical devices. The device on the left is a larger, wheeled machine with a display screen and various controls. It has a light-colored body with a darker top section and a foot pedal. The device on the right is smaller and more compact, labeled "Litho DK". It also features a display screen and several buttons, indicating it is a medical device for lithotripsy.
Picture 7-1 - device Litho (on left) and Litho DK30 (on right) 7-3
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Intended Use/Indications for Use
The modified device Litho DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX).
This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909) because Litho DK30 is the desktop version of the already cleared device Litho (K09109).
The modified device Litho DK30 share the same architecture and the same laser source of the unmodified device Litho: both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um, with no change in the fundamental scientific technology of the device.
The modified device Litho DK30 has the same intended use of the unmodified device. Moreover the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
The Intended Use/Indication for use statement of the unmodified device (Litho - K091009) has been analyzed. In the original statement there is not a clear definition (separation) of the Intended use and of the Indications for use and thus a revised statement is proposed.
The revised version of the statement has separated sections for the Intended Use and for the Indications for use.
Moreover, in order to have a more understandable definition of the Indications for use, it has been removed the (long) list of diseases/surgical operations given in K091909 because this list, as said by several physicians, does not add useful information.
Thus the Intended Use is:
The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic, to perform incision, excision, excision, resection, ablation, vaporization, coaqulation and hemostasis of soft tissue and in Lithotripsy of stones.
And the Indications for use are:
The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to: Urology, Gastroenterology, Arthroscopy, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology , Plastic Surgery and General Surgery.
The modified device Litho DK30 has the same intended use of the unmodified device.
Moreover the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.
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Substantial Equivalence:
This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909) because because Litho DK30 is the desktop version of the already cleared device Litho (K09109).
The modified device Litho DK30 share the same architecture and the same laser source of the unmodified device Litho: 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 Litho DK30 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.
Thus the modified device Litho DK30 is substantially equivalent to the previously legally marketed device Litho (K091909).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The caduceus is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Quanta System SPA Mr. Maurizio Bianchi Regulatory Affairs Manager Via IV Novembre, 116 Solbiate Olona (VA) Italy, 21058
Re: K141403
Trade/Device Name: Litho DK30 (and its accessories) 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 7, 2014 Received: July 8, 2014
Dear Mr. Bianchi:
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
6
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 (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. 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.
Sincerely yours,
David Krause -S
for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141403
Device Name Litho DK30
Indications for Use (Describe)
INTENDED USE
The device Litho DK30 including a fiber optic delivery system is intended to be used 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.
INDICATIONS FOR USE
The device Litho DK30 including a fiber optic delivery system is insurgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (2) 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)
David Krause -S 2014.08.18 13:46:18 -04'00'
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