(210 days)
Not Found
No
The document describes a laser device for surgical procedures and does not mention any AI or ML capabilities. The performance studies focus on tissue effects and comparison to a predicate device, not on algorithmic performance.
Yes
This device is a surgical laser intended for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of tissue across multiple medical specialties, which are all therapeutic interventions designed to treat medical conditions.
No
The device is described as a laser system intended for use in various surgical procedures, including incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of tissue, which are all therapeutic interventions, not diagnostic ones.
No
The device description explicitly states it is a "diode laser operating at 1950nm with a maximum power output of 50W," which is a hardware device. The intended use and performance studies also describe procedures and testing involving physical tissue interaction, further indicating it is 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 surgical procedures performed directly on the human body (incision, excision, resection, ablation, vaporization, coagulation, and hemostasis) across various anatomical sites.
- Device Description: The device is a laser system designed to deliver energy for these surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for therapeutic and surgical interventions.
N/A
Intended Use / Indications for Use
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral strictures .
- Bladder neck incisions .
- Ablation and resection of bladder tumors, urethral tumors and . ureteral tumors
- Ablation of Benign Prostatic hypertrophy (BPH)
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostate (HoLRP)
- Laser Enucleation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of the external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy .
- Polyps
- Biopsv ●
- Gall Bladder calculi
- Biliary/bile duct calculi t
- Ulcers .
- Gastric ulcers .
- Duodenal ulcers .
- . Non-bleeding ulcers
- . Pancreatitis
- Hemorrhoids .
- Cholecystectomy .
- Benign and malignant neoplasm .
- . Angiodysplasia
- Colorectal cancer .
- Telangiectasias .
- Telangiectasias of the Osler-Weber-Renu disease .
- Vascular malformation .
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric erosions ●
Thoracic/Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Laryngeal lesions .
- Airway obstruction including carcinoma .
- Polyps and granulomas .
- Palliation of obstructing carcinomas of the tracheobronchial tree .
Gynecology
Open and endoscopic surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including:
- Intra uterine treatment of submucous fibroids, benign . endometrial polyps and uterine septum by incision, excision, ablation and or vessel coagulation
- Soft tissue excision procedures such as excisional conization of . the cervix
Ear, Nose and Throat (Otolaryngology)
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Endonasal/sinus surgery .
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy ●
- Frontal sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
Dermatology/Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic procedures including:
- Basal Cell carcinomas .
- Lesions of the skin and subcutaneous tissue ●
- Skin tags .
- Plantar warts
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
- Ablation of soft and cartilaginous tissue in minimally invasive . spinal surgery including:
- Percutaneous laser disc decompression/discectomy ♥
- Foraminoplasty .
- Ablation and coagulation of soft vascular and non . vascular tissue
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystecomy
- Lysis of adhesions
- Appendectomy
- Biopsv
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy
- Pancreatectomy
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
- Debridement of decubitus ulcers
- Hemorrhoids
- Debridement of statis ulcers
- Biopsy
Product codes
GEX
Device Description
The Ceralas D1950 is a diode laser operating at 1950nm with a maximum power output of 50W.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethral, Bladder, Ureteral, Prostate, External genitalia, Appendix, Colon, Biliary/bile duct, Stomach, Duodenum, Pancreas, Rectum, Gallbladder, Liver, Esophagus, Larynx, Tracheobronchial tree, Uterus, Endometrial, Cervix, Nose, Sinuses, Oral, Pharyngeal, Skin, Subcutaneous tissue, Cartilaginous tissue, Spinal disc, Abdomen, Breast, Thyroid, Parathyroid, Lymph nodes, Kidney
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)
Bench testing was performed to compare the vaporization, cutting, and coagulation rates of the Ceralas D1950 and a 2010nm laser. The lasers were directed at potato slices and porcine muscle tissue to evaluate vaporization, and cutting and coagulation were evaluated with porcine liver, skin, and muscle tissue. Similar parameters were employed with each laser to test the effects of the Ceralas D1950 and the 2010mm lasers on the target tissue for each of these tests. The testing demonstrated substantially equivalent performance and tissue effects between the Ceralas D1950 and the 2010mm laser device.
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
510(k) SUMMARY
Biolitec Inc.'s 50W Ceralas Diode 1950nm Laser System (Model D1950)
APR 1 8 2008
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson 555 13th Street NW Washington DC 20004
Phone: 202 637-5794 Facsimile: (202) 637-5910
Jonathan S. Kahan Contact Person:
September 20, 2007 Date Prepared:
Name of Device and Name/Address of Sponsor
50W Ceralas D 1950nm Diode Laser (Model D1950)
Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Common or Usual Name
Diode Laser
Classification Name
Laser, Surgical Diode Laser System
Product Code and Regulation Number
GEX, 21 C.F.R. 878.4810
Predicate Devices
AllMed Revolix 120 Laser Systems (K033423, K051167, K070476)
1
pg 2 of 5
Intended Use / Indications for Use
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral strictures .
- Bladder neck incisions .
- Ablation and resection of bladder tumors, urethral tumors and . ureteral tumors
- Ablation of Benign Prostatic hypertrophy (BPH)
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostate (HoLRP)
- Laser Enucleation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of the external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy .
- Polyps
- Biopsv ●
- Gall Bladder calculi �
- Biliary/bile duct calculi t
- Ulcers .
- Gastric ulcers .
- Duodenal ulcers .
- . Non-bleeding ulcers
- . Pancreatitis
- Hemorrhoids .
- Cholecystectomy .
- Benign and malignant neoplasm .
- . Angiodysplasia
- Colorectal cancer .
- Telangiectasias .
- Telangiectasias of the Osler-Weber-Renu disease .
- Vascular malformation .
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
2
Pg 3-4-5
- Mallory-Weiss tear
- Gastric erosions ●
Thoracic/Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including
- Laryngeal lesions .
- Airway obstruction including carcinoma .
- Polyps and granulomas .
- Palliation of obstructing carcinomas of the tracheobronchial tree .
Gynecology
Open and endoscopic surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including
- Intra uterine treatment of submucous fibroids, benign . endometrial polyps and uterine septum by incision, excision, ablation and or vessel coagulation
- Soft tissue excision procedures such as excisional conization of . the cervix
Ear, Nose and Throat (Otolaryngology)
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Endonasal/sinus surgery .
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy ●
- Frontal sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
3
072682 pg 4-5
Dermatology/Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic procedures including:
- Basal Cell carcinomas .
- Lesions of the skin and subcutaneous tissue ●
- Skin tags .
- Plantar warts
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
- Ablation of soft and cartilaginous tissue in minimally invasive . spinal surgery including:
- Percutaneous laser disc decompression/discectomy ♥
- Foraminoplasty .
- Ablation and coagulation of soft vascular and non . vascular tissue
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystecomy �
- Lysis of adhesions
- Appendectomy
- Biopsv
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy
- Pancreatectomy
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
4
pg 5 - 1-5
- Debridement of decubitus ulcers
- Hemorrhoids
- Debridement of statis ulcers
- Biopsy
Technological Characteristics
The Ceralas D1950 is a diode laser operating at 1950nm with a maximum power output of 50W.
Performance Data
Bench testing was performed to compare the vaporization, cutting, and coagulation rates of the Ceralas D1950 and a 2010nm laser. The lasers were directed at potato slices and porcine muscle tissue to evaluate vaporization, and cutting and coagulation were evaluated with porcine liver, skin, and muscle tissue. Similar parameters were employed with each laser to test the effects of the Ceralas D1950 and the 2010nm lasers on the target tissue for each of these tests. The testing demonstrated substantially equivalent performance and tissue effects between the Ceralas D1950 and the 2010mm laser device.
Substantial Equivalence
The Ceralas D1950 is as safe and effective as AllMed Revolix Laser Systems (K033423, K051167, K070476). The Ceralas D1950 has the same intended uses and indications, and similar technological characteristics, and principles of operation as its predicate devices. Thus, the Ceralas D1950 is substantially equivalent.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolitec, Inc. % Hogan & Hartson, LLP Mr. Johnathan S. Kahan 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K072682
Trade/Device Name: 50W Ceralas D 1950nm Diode Laser (Model D1950) 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: March 10, 2008 Received: March 10, 2008
APR 1 8 2008
Dear Mr. Kahan:
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 such 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); good manufacturing practice requirements as set
6
Page 2 – Mr. Johnathan S. Kahan
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Pg 1 of 4
Indications for Use Statement
510(k) Number (if known): K072682
50W Ceralas D 1950nm Diode Laser (Model D1950) Device Name:
Indications for Use:
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral strictures �
- Bladder neck incisions �
- Ablation and resection of bladder tumors, urethral tumors and ureteral tumors
- Ablation of Benign Prostatic hypertrophy (BPH)
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostate (HoLRP)
- Laser Enucleation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of the external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
B' : "rice
- Appendectomy ●
- Polyps
- Biopsv
- Gall Bladder calculi
- Biliary/bile duct calculi
- Ulcers
- ਾ ਪ Gastric ulcers
- Duodenal ulcers
- Non-bleeding ulcers
- Pancreatitis
- Hemorrhoids
- Cholecystectomy
- Benign and malignant neoplasm
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
Nilkl Gel for mxn
Division Sign-Off
Division of General, Restorative. and Neurological Devices
510(k) Number K072682
8
107268
- Telangiectasias of the Osler-Weber-Renu disease
- Vascular malformation
- Gastritis Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric erosions
Thoracic/Pulmonary Surgery
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including
- Laryngeal lesions .
- Airway obstruction including carcinoma
- Polyps and granulomas
- Palliation of obstructing carcinomas of the tracheobronchial tree
Gynecology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including
- Intra-uterine treatment of submucous fibroids, benign . endometrial polyps and uterine septum by incision, excision, ablation and or vessel coagulation
- Soft tissue excision procedures such as excisional conization of the cervix
Ear. Nose and Throat (Otolaryngology)
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: .
- Endonasal/sinus surgery .
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- Frontal sinusotomy
- Ethmoidectomy ●
- Maxillary antrostomy .
- � Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and . laryngeal
(Division Sign=Of Division of General, Restorative, and Neurological Devices
- Tonsillectomy Adenoidectomy
510(k) Number_Ko72682
9
K072682 Pg 3 of 4
Dermatology/Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic procedures including:
- Basal Cell carcinomas .
- Lesions of the skin and subcutaneous tissue
1 ···
- Skin tags
- Plantar warts
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
-
Ablation of soft and cartilaginous tissue in minimally invasive . spinal surgery including:
r. 1 . " !!# -
Percutaneous laser disc decompression/discectomy
-
Foraminoplasty
-
Ablation and coagulation of soft vascular and non vascular tissue
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystecomy ●
- Lysis of adhesions
- Appendectomy
- Biopsy
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy .
- Pancreatectomy .
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
Neil Re Opln for mkm
Division Sign Off
Division of General, Restorative. and Neurological Devices
510(k) Number K072682
10
Pg 4 of 4
- 1 1 1 -
- Debridement of decubitus ulcers
- Hemorrhoids :
- Debridement of statis ulcers
- Biopsy
Prescription Use __ X. (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden-Erskine
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 4 of 4
510(k) Number_clock) 22682