(30 days)
No
The summary describes a laser system for soft tissue procedures and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes
The device is indicated for surgical applications involving vaporization, excision, ablation, cutting, hemostasis, and coagulation of soft tissue, which are all therapeutic actions.
No
The device is indicated for surgical applications requiring vaporization, excision, ablation, cutting, hemostasis, or coagulation of soft tissue, which are therapeutic rather than diagnostic actions.
No
The device description explicitly lists hardware components such as a laser console, footswitch, and delivery device accessories in addition to operating software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a laser system used for surgical applications requiring the vaporization, excision, ablation, cutting, hemostasis, or coagulation of soft tissue. These are all procedures performed on the patient's body (in vivo).
- Intended Use: The intended use describes surgical procedures in various medical specialties, not laboratory testing of specimens.
Therefore, the Modified INTERmedic Diode Laser 980nm System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology). Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal. General Surgery, Ophthalmology, Orthopodics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
Product codes
GEX
Device Description
The modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 180), and the delivery accessories that are used with it, is comprised of the following main components:
- Laser console with fiber port and RF ID bracket
- Operating software
- Detachable footswitch
- Delivery device accessories (fiber optic, handpieces and scanner)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue in various anatomical locations as described in the Indications for Use, including but not limited to: external genitalia, prostate, bladder, rectum, anus, breast, bowel, liver, thyroid, spine/disc, meninges, cervix, uterus, ovaries, eye, joints, colon, esophagus, ear, nose, throat, larynx, vocal cords, teeth, heart, face, extremities, legs, and saphenous veins.
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.
0
1
KO91323
Appendix G - 510(k) Summary for the Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180)
I. General Information
Submitter:
INTERmedic Arfran, S.A. Avda. Josep Tarradellas, 91 08029 Barcelona SPAIN
Contact Person:
Francesc Sota Technical Director, INTERmedic Arfran, S.A.
Summary Preparation Date: June 2, 2009
II.
- Device Names:
Names
Primary Classification Names:
Laser Powered Surgical Instruments (and accessories)
Modified INTERmedic Diode Laser 980nm System
III. Predicate Devices
-
INTERmedic Arfran, S.A. INTERmedic Diode Lascr Diode Family (K053540) .
(MULTIDIODE SST 180) -
Biolitec. Inc. 180W Ceralas D 980nm Diode Laser (Model D180) (K083682) .
IV. Product Description
The modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 180), and the delivery accessories that are used with it, is comprised of the following main components:
- . Laser console with fiber port and RF ID bracket
- A Operating software
- 바 Detachable footswitch
- Delivery device accessories (fiber optic, handpieces and scanner)
V. Indications for Use
The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology). Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal. General Surgery, Ophthalmology, Orthopodics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
1
The Indications for Use of the modificd INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) are provided in Appendix D.
VI. Rationale for Substantial Equivalence
The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate INTERmedic Diode Laser Family (K053540) and shares similar functional capabilities as the predicate Biolitec 180W Ceralas D 980nm Diode Laser (Model D180) (K083682).
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is substantially cquivalent to the predicate INTERmedic Diode Laser Family (K053540) and the predicate Biolitec 180W Ceralas D 980nm Diode Laser (Model D180) (K083682):
VIII. Conclusion
The modified INTERmedic Diode Lascr 980nm System (MULTIDIODE SST 180) was found to be substantially equivalent to the predicate devices.
The modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
INTERmedic Afran S.A. % A.L. Voss Associates Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566
JUN - 4 2009
Re: K091323
Trade/Device Name: The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180)
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: May 1, 2009 Received: May 5, 2009
Dear Ms. Worden:
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 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 of medical
3
Page 2 - Ms. Anne Worden
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at it's Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)
Indications for Use:
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 180) is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovasoular coagulation, Oral Surgery and Dental procedures.
Examples include:
Laser 980 nm
Urology:
- · Lesions of external genitalia
- · Circumcision
- · Condyloma
- · Bladder tumors
- · Bladder neck incisions
- · Vaporization of the prostate.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
** 6 pages total ***
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Ko9/323
Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-2 Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 200)
5
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)
Indications for Use: Continued
Laser 980 nm
General Surgery:
· Rectal and anal hemorrhoidectomy
· Mastectomy
· Dermabrasion
· Appendectomy (open and laparoscopic)
· Bowel resection (open and laparoscopic)
· Colectomy
· Liver resection
· Resections of organs
· Thyriodectomy
• Adhesiolysis
· Hepatobiliary tumors
· Throacotomy
· Cholecystectomy (open and laparoscopic)
· Condyloma
· Breast biopsy
Neurosurgery:
· Percutaneous Disc Decompression
· Discectomy
· Hemostasis in conjunction with meningiomas
*** 6 pages total ***
Prescription Use く Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091322
Page 2 of 6
Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-3 Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 200)
6
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)
Indications for Use: Continued
Laser 980 nm
Gynecology:
- · Cervical conization
- · Myomectomy
- · Endometrial ablation
- · Ovarian cystectomy
- · Appendectomy
Ophthalmology:
-
· Dacryocystorhinostomy transcanalicular
• Open DCR -
· Tumor excision
-
· Blepharoplasty
Orthopedics:
- Dissect and coagulate
Gastroenterology:
- · Hemostasis of colonoscopy
- · Hemostasis of esophageal varicies
- · Excision of polyps
Arthroscopy:
- · Chondromalacia
- · Synovectomy
- · Menisectomy
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
*** 6 pages total ***
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number 1609/323
Page 3 of
Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-4 Modified INTERmedic Diode Laser 980nm System (MULTIDIODE SST 200)
135
б
7
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)
Indications for Use: Continued
Laser 980 nm
Thoracic Surgery:
- · Thoracotomy
- · Pulmonary resection
- · Hemostasis
- · Pericardiectomy
- · Adhesiolysis
- · Coagulation of blebs and bullae
Pulmonology:
- · Endoscopic pulmonary applications
- · Tracheal bronchial lesions
- · Benign and malignant pulmonary obstruction
Otolaryngology ENT:
- · Removal of benign lesions from the ear, nose and throat
- · Excision of carcinoma of the larynx
- · Incision and excision of carcinoma in situ
- · Neck dissection
- · Laryngeal papillomectomy
- · Removal of vocal cord/fold nodules, polyps and cysts
*** 6 pages total ***
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | 2091323 |
Page 4 of 6
Special 510 (k) Premarket Notification for: Appendix D: FDA Indications for Use - Page D-5 Modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 200)
8
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)
Indications for Use: Continued
Laser 980 nm
Dental Applications:
- · Frenectomy
- · Frenotomy
- · Biopsy
- · Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening
Pulmonary Surgery:
- · Endoscopic pulmonary applications
- · Tracheal bronchial lesions
- · Benign and malignant pulmonary or stricture
Cardiac Surgery:
- · Coagulation and hemostasis of cardiac tissue
Dermatology/ Aesthetics:
- · Photocoagulation of vascular & dermatological lesions of the face and extremities
- · Photocoagulation of telangiectasis, veinulectasisas of the legs and face
- · Treatment of reticular veins and branch varicosities
- · Pyogenic granuloma, lymphangioma and lymphagiomatosis disease, angiofibromas
- · Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venus lakes, Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.
*** 6 pages total ***
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | 109/323 |
|---|---|
| --------------- | --------- |
Page 5 of 6
Special 510 (k) Premarket Notification for: Appendix D. FDA Indications for Use - Page D-6 Modified INTERmedic Diode Laser 980mm System (MULTIDIODE SST 200)
9
The Modified INTERmedic Diode Laser 980nm System (MULTIDIODE Device Name: SST 180)
Indications for Use: Continued
Laser 980 nm
Dermatology/ Aesthetics: Continued
- · Dermatological surgery: Chondyloma acuminate, warts, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcoma. Warty leucoplasy and ulcers debridement.
- · Seborrheic keratoses
- Mixoid cyst
- · Papillary varix
- · Acne treatment
- · Hair removal of unwanted hair from skin types 1-V
Plastic Surgery:
- · Cut, coagulation & vaporization
- · Resurfacing
- · Blepharoplasty
Vascular Surgery:
· Endoluminal or endovenous laser surgery for saphenous incompetent veins
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
*** 6 pages total ***
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | C05/323 |
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