(101 days)
Not Found
No
The document describes a laser surgical instrument for soft tissue and stone lithotripsy, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is explicitly stated to perform various surgical procedures such as incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, and lithotripsy of stones, which directly treat medical conditions.
No
The device's intended use is to perform surgical procedures (incision, resection, ablation, vaporization, coagulation, hemostasis, and lithotripsy), not to diagnose conditions.
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, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Laser surgical instrument" intended for use in "surgical procedures" to perform actions like "incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones." These are all procedures performed within the living body (in vivo).
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the Litho device described is a surgical laser system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device Litho 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 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 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
The modified device Litho 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 is submitted due to Device Modifications of the already cleared device Litho (K091909) because of the incremental changes from the original clearance K091909. Is included the update to the third edition of IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and to the collateral standards.
The modified device Litho 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.
Under the new 510(k) Paradigm, referring to 21 CFR 807.81(a)(3) and the FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, the following modifications have been implemented on the cleared device Litho (K091909) without submitting a new 510(k):
- An alternative power-supply from a second source has been qualified.
- The water pump of the cooling system has been changed to improve the cooling efficiency.
- The water-to-air heat-exchanger has been changed to improve the cooling efficiency.
- The technical specifications of lens focusing the laser beam into the optical fiber has been changed to improve the incoupling.
- The footswitch connector has been moved to the front side of the device to improve the usability.
- A white LED ring around the fiber connector is lighting when the fiber is properly connected to the device (fiber interlock OK)
- An RFID recognition system has been added to read the fiber diameter directly from the fiber equipped with the suitable transponder.
- Review of the combinations of the laser parameters (energy and frequency) achievable within 30 W maximum power (upon physicians' feedbacks).
- The GUI (Graphic User Interface) has been changed to improve the readability (upon physicians' feedbacks).
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
Surgical procedures (open, laparoscopic, endoscopic) by physicians in medical specialties including Urology, Gastroenterology, Arthroscopy, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
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.
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
Quanta
Special 510(K) SUMMARY - Device Modifications
Introduction:
This document contains the 510(k) Summary for the device Litho. 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: | April 30th, 2014 |
| Device Name: | Litho |
| 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 is claimed to be derived from the legally marketed (unmodified) device Litho (K091909) because of Device modifications - update to the Third edition of IEC 60601-2-22 (basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment).
Performance Standards:
There are no mandatory performance standards for this device.
1
General Device Description:
The modified device Litho 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 is submitted due to Device Modifications of the already cleared device Litho (K091909) because of the incremental changes from the original clearance K091909. Is included the update to the third edition of IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and to the collateral standards.
The modified device Litho 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 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, 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, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgerv.
The modified device Litho is claimed to be derived from the legally marketed (unmodified) device Litho (K091909) because of the incremental changes from the original clearance K091909. Is included the update to the third edition of IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and to the collateral standards.
Description of the modifications:
The modified device Litho 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 is submitted due to Device Modifications of the already cleared device Litho (K091909) because of the incremental changes from the original clearance K091909. Is included the update to the third edition of IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and to the collateral standards.
2
The modified device Litho 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 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.
Under the new 510(k) Paradigm, referring to 21 CFR 807.81(a)(3) and the FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, the following modifications have been implemented on the cleared device Litho (K091909) without submitting a new 510(k):
- An alternative power-supply from a second source has been qualified. ।
- -The water pump of the cooling system has been changed to improve the cooling efficiency.
- The water-to-air heat-exchanger has been changed to improve the cooling efficiency. -
- The technical specifications of lens focusing the laser beam into the optical fiber has been changed to improve the incoupling.
- The footswitch connector has been moved to the front side of the device to improve the usability.
- A white LED ring around the fiber connector is lighting when the fiber is properly connected to the device (fiber interlock OK)
- An RFID recognition system has been added to read the fiber diameter directly from the । fiber equipped with the suitable transponder.
- Review of the combinations of the laser parameters (energy and frequency) achievable . within 30 W maximum power (upon physicians' feedbacks).
- The GUI (Graphic User Interface) has been changed to improve the readability (upon physicians' feedbacks).
During 2013 it has been performed the upgrade to the third edition of IEC 60601-1 and to its collateral standards for the European market (CE mark).
The upgrade to the third edition of the IEC 60601-1 and to its collateral standards leads 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. All the modifications implemented until 2013 have been reevaluated following the requirements of third edition of IEC 60601-1 and to its collateral standards.
Taking into account the FDA guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, the upgrade to the third edition of the IEC 60601-1 and to its collateral standards has been evaluated as a relevant step of the evolution of the device and therefore it has been decided to submit this Special 510(k).
The overall dimensions and external appearance of the modified device are the same as the unmodified device (see picture 1-1)
3
Image /page/3/Picture/0 description: The image shows a medical device labeled "Litho" on the front. The device has a screen on the top and several buttons and knobs on the front panel. It is mounted on wheels and has a foot pedal attached to it.
Picture 1-1 - device Litho
Intended Use/Indications for Use
The modified device Litho 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 is submitted due to Device Modifications of the already cleared device Litho (K091909) because of the incremental changes from the original clearance K091909. Is included the update to the third edition of IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and to the collateral standards.
The modified device Litho 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 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 Intended Use/Indication for use statement of the unmodified device (Litho - K091009) has
4
been analized. 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 Inteded 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, resection, ablation, vaporization, coagulation 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, 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, Neurosurgery, Pulmonary, Gynecology, ENT, Dermatology , Plastic Surgery and General Surgery.
The modified device Litho 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.
Substantial Equivalence:
This Special 510(k) of the modified device Litho is submitted due to Device Modifications of the already cleared device Litho (K091909) because of the incremental changes from the original clearance K091909. Is included the update to the third edition of IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and to the collateral standards.
The modified device Litho 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 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 is substantially equivalent to the previously legally marketed device Litho (K091909).
5
Image /page/5/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2014
Quanta System SpA Mr. Maurizio Bianchi Regulatory Affair Manager Via IV Novembre, 116 Solbiate Olona (VA) 21058, Italy
Re: K141101 Trade/Device Name: Litho 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: June 12, 2014 Received: June 16, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Mr. Maurizio Bianchi
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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141101
Device Name Litho
Indications for Use (Describe)
INTENDED USE
The device Litho 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 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 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 CTR 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 I lealth (CDRH) (Signature)
for BSA
8
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources. gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."