(132 days)
Not Found
No
The summary describes a laser device for therapeutic heating and surgical ablation. There is no mention of AI or ML in the device description, intended use, or performance studies. The control electronics manage basic functions like power, user interface, and temperature, which are standard for such devices and do not indicate AI/ML.
Yes
The device is intended to provide topical heating for temporary relief of pain and stiffness, increase local blood circulation, and temporary relaxation of muscle, as well as for surgical ablation, vaporization, excision, incision, and coagulation of soft tissue, all of which are considered therapeutic applications.
No
The device is intended to emit energy for topical heating and for surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue. These are therapeutic, not diagnostic, functions.
No
The device description clearly outlines multiple hardware components including a laser console, power electronics, touch screen display, laser system (source, cooling, fiber launching, aiming beam), optical fiber, and handpieces. This is not a software-only device.
Based on the provided information, the Guardian 1000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as providing topical heating and performing surgical procedures (ablation, vaporization, excision, incision, and coagulation) directly on the patient's body. IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a laser system that delivers energy to the patient via an optical fiber and handpieces. This is consistent with a device used for direct treatment on a living organism, not for analyzing samples in a lab.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The Guardian 1000 is a therapeutic device used for direct treatment on the patient.
N/A
Intended Use / Indications for Use
Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation. vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ILY, PDZ
Device Description
Guardian 1000 delivers an invisible laser beam in the infrared spectrum at 980 nm using a gallium aluminum arsenide (GaAlAs) source. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers.
Guardian 1000 consists of two main sub-systems: a laser console and its delivery accessories, as follows: The laser console includes:
- an external enclosure
- power electronics
- touch screen display with control electronics which controls:
- power electronics
- user interface
- laser source temperature
- laser source emission
- a laser system including:
- laser source
- cooling system (Peltier cells, dissipator and fans)
- fiber launching system
- aiming beam
Laser radiation is delivered to the patient trough an optical fiber and several handpieces depending on the treatment.
The optical fiber is connected to the laser unit trough a SMA905 connector
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry. Specific applications listed include:
- Gastroenterology: esophageal varices, malignant dysphagia, obstructive neoplasms, colon.
- Neurosurgery: Tumors adjacent to the spinal cord; tumors adjacent to the cortex.
- General Surgery: appendectomy, cholecystectomy, bowel resection, mastectomy, reduction mammoplasty, breast biopsy, rectal and anal hemorrhoidectomy, liver resection, condyloma, thyroidectomy, thoracotomy, cavernous hemangioma.
- Genitourinary (Urology): prostate, bladder, urethra, external sphincter, lymph nodes, external genitalia.
- Thoracic Surgery: Pulmonary, blebs and bullae, adhesions, pericardium, mediastinal and thoracic lesions, mediastinal lymph node.
- Gynecology (GYN): adhesions, endometrial lesions, endometriosis, hysterectomy, uterosacral nerve, myomectomy, ovarian cystectomy, ovarian drilling, tubal fimbrioplasty, cervix, vulva, vagina, perineum, intrauterine (fibroids, polyps, adhesions, septum).
- Pulmonology: Tracheal bronchial lesions.
- Ophthalmology: Oculoplastics, DCR (open and endo-nasal), eyelid.
- Orthopedics: Not specified beyond "Dissect and coagulate".
- Otolaryngology (ENT): Nasal/Sinus (turbinate, polyp, ethmoid, meatal antrostomy), Laryngo-tracheal (vocal cord/fold, arytenoid, tracheal), Oropharyngeal (uvulopalatoplasty, tonsillectomy, hemi glossectomy), Head & Neck (oral, sub facial, neck tissues, parathyroid).
- Podiatry: Nail matrix, periungual and subungual warts, plantar warts, neuromas, nails with onychomycosis.
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 following performance data are provided in support of the substantial equivalence determination:
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Guardian 1000 device and its delivery accessories.
The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The Guardian 1000 device is capable of achieving therapeutic temperature range of 40 - 45 degrees centigrade as accepted by the FDA. An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing. The therapeutic temperature range was maintained for over 10 minutes testing time. The temperatures versus time measurements were conducted on 3 subjects at 2 physical locations (shoulder and knee areas). The preexposed topical skin temperature ranged from 31.8 to 34.3 centigrade degrees. The topical temperature during exposure following brief stabilization time ranged from 40.8 to 43.9 centigrade degrees. These data demonstrate the System meets the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade during the recommended treatment time of 10 minutes.
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.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with a design above them that resembles a bird or abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ouanta System SPA Mr. Francesco Dell'Antonio Compliance Manager Via IV Novembre, 116 Solbiate Olona (VA) Italy, 21058
October 27, 2015
Re: K151629 Trade/Device Name: Guardian 1000 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, ILY, PDZ Dated: September 25, 2015 Received: September 28, 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 CFR Part 807); labeling (21 CFR Part 801 and 809]); medical device reporting
1
(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/Resourcesfor You/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,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
For Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151629
Device Name
Guardian 1000
Indications for Use (Describe)
Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation. vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.
Gastroenterology
Hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis in colonoscopy.
Neurosurgery
Tumors adjacent to the spinal cord; tumors adjacent to the cortex.
General Surgery
Ablation, vaporization, excision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include but are not limited to: Laparoscopic: appendectomy, cholecystection. Open: mastectomy, reduction mammoplasty, breast biopsy, rectal and anal hemorrhoidectomy, bowel resection, colectomy, cholecystectomy, liver resection, condyloma, thyroidectomy, cavernous hemangioma.
Genitourinary (Urology)
Transurethral: transurethral incision of the prostate (TUIP), bladder neck incisions, urethral strictures, exterior sphincterotomy, laparoscopic lymphadenectomy. Open: condyloma, circumcision, benign and malignant lesions of external genitalia.
Thoracic Surgery
Pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectorny, mediastinal and thoracic lesions and abnormalities, mediastinal lymph node dissection, hemostasis: thoracotomy,
Gynecology (GYN)
Laparoscopic excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA); myomectomy; ovarian drilling, tubal fimbrioplasty, appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN, condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erithroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/ polyps/adhesions; Resection of septum.
Pulmonology Tracheal bronchial lesions.
3
Ophthalmology
Oculoplastics, open DCR, endo-nasal DCR, tumor excision and biopsy, eyelid reconstruction; blepharoplasty.
Orthopedics Dissect and coagulate.
Otolaryngology (ENT)
Nasal/Sinus: turbinectomy and turbinate reduction; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy;
Laryngo-tracheal: removal of vocal cord/ fold nodules, polyps and cysts; arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy;
Head & Neck: tumor resection on oral, sub facial and neck tissues; parathyroidectomy;
Podiatry
Matrixectomy, Periungual and subungual warts, Plantar warts, Neuromas.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and /or yeasts Candida albicans, etc.).
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)
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5. 510(K) SUMMARY
Introduction:
This document contains the 510(k) Summary for the Guardian 1000 laser device. 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: | June 4th 2015 |
| Device Name: | Guardian 1000 |
| 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, ILY, PDZ |
Predicate Devices:
Guardian 1000 is substantially equivalent to the following legally marketed predicate devices:
5
Description of the device:
Guardian 1000 delivers an invisible laser beam in the infrared spectrum at 980 nm using a gallium aluminum arsenide (GaAlAs) source. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers.
Guardian 1000 consists of two main sub-systems: a laser console and its delivery accessories, as follows: The laser console includes:
- i an external enclosure
- । power electronics
- touch screen display with control electronics which controls:
- o power electronics
- O user interface
- o laser source temperature
- laser source emission o
- . a laser system including:
- O laser source
- cooling system (Peltier cells, dissipator and fans) o
- fiber launching system o
- aiming beam o
Laser radiation is delivered to the patient trough an optical fiber and several handpieces depending on the treatment.
The optical fiber is connected to the laser unit trough a SMA905 connector
Intended use
Guardian 1000 with its delivery accessories is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.
Gastroenterology
Hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis in colonoscopy.
Neurosurgery
Tumors adjacent to the spinal cord; tumors adjacent to the cortex.
General Surgery
Ablation, vaporization, excision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include but are not limited to: Laparoscopic: appendectomy, cholecystectomy, bowel resection. Open: mastectomy, reduction mammoplasty,
6
breast biopsy, rectal and anal hemorrhoidectomy, bowel resection, cholecystectomy, liver resection, condyloma, thyroidectomy, thoracotomy; cavernous hemangioma.
Genitourinary (Urology)
Transurethral: transurethral incision of the prostate (TUIP), bladder tumors, bladder neck incisions, urethral strictures, exterior sphincterotomy, laparoscopic lymphadenectomy. Open: condyloma, circumcision, benign and malignant lesions of external genitalia.
Thoracic Surgery
Pulmonary resection, coagulation of blebs and bullae, adhesiolysis, pericardiectomy, mediastinal and thoracic lesions and abnormalities, mediastinal lymph node dissection, hemostasis; thoracotomy.
Gynecology (GYN)
Laparoscopic excision/lysis of adhesions, endometrial lesions, including ablation of endometriosis, laparoscopic assisted hysterectomy (LAVH), laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy, ovarian drilling, tubal fimbrioplasty, appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN, condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erithroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/ polyps/adhesions; Resection of septum.
Pulmonology
Tracheal bronchial lesions.
Ophthalmology
Oculoplastics, open DCR, endo-nasal DCR, tumor excision and biopsy, evelid reconstruction; blepharoplasty.
Orthopedics
Dissect and coagulate.
Otolaryngology (ENT)
Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy;
Laryngo-tracheal: removal of vocal cord/ fold nodules, polyps and cysts; arytenoidectomy; tracheal stenosis;
Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy;
Head & Neck: tumor resection on oral, sub facial and neck tissues; parathyroidectomy;
Podiatry
Matrixectomy, Periungual and subungual warts, Plantar warts, Neuromas.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and /or yeasts Candida albicans, etc.).
Comparison of Technological Characteristics:
7
Guardian 1000 has the same technological characteristics (energy source, control mechanism) and specifications as its predicate devices.
Performance data:
The following performance data are provided in support of the substantial equivalence determination:
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Guardian 1000 device and its delivery accessories.
The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The Guardian 1000 device is capable of achieving therapeutic temperature range of 40 - 45 degrees centigrade as accepted by the FDA. An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing. The therapeutic temperature range was maintained for over 10 minutes testing time. The temperatures versus time measurements were conducted on 3 subjects at 2 physical locations (shoulder and knee areas). The preexposed topical skin temperature ranged from 31.8 to 34.3 centigrade degrees. The topical temperature during exposure following brief stabilization time ranged from 40.8 to 43.9 centigrade degrees. These data demonstrate the System meets the generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade during the recommended treatment time of 10 minutes.
Comparison of Intended Use:
Guardian 1000 device's Intended Use combines the Intended Uses of its predicate devices.
Substantial Equivalence:
The Guardian 1000 device and its delivery system is as safe and effective as its predicate devices. The Guardian 1000 device and its delivery system has the same intended use, technological characteristics and specifications as its predicate devices.
Thus, Guardian 1000 device and its delivery system is substantially equivalent to its predicate devices.