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

Device Description

The Ceralas D1950 is a diode laser operating at 1950nm with a maximum power output of 50W.

AI/ML Overview

This 510(k) summary describes a medical device, the Biolitec Inc.'s 50W Ceralas Diode 1950nm Laser System (Model D1950), which is a surgical diode laser. The provided document details its intended uses and compares its performance to a predicate device for substantial equivalence.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical quantitative sense (e.g., a specific numerical threshold for accuracy or a statistical measure). Instead, the acceptance criterion for regulatory clearance appears to be "substantially equivalent performance" to a legally marketed predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Substantially equivalent vaporization rates to predicate 2010nm laser	Bench testing demonstrated substantially equivalent performance on potato slices and porcine muscle tissue.
Substantially equivalent cutting rates to predicate 2010nm laser	Bench testing demonstrated substantially equivalent performance on porcine liver, skin, and muscle tissue.
Substantially equivalent coagulation rates to predicate 2010nm laser	Bench testing demonstrated substantially equivalent performance on porcine liver, skin, and muscle tissue.
Similar tissue effects to predicate 2010nm laser	Testing demonstrated similar tissue effects between the Ceralas D1950 and the 2010nm laser.
Same intended uses and indications as predicate devices	Stated in the "Substantial Equivalence" section.
Similar technological characteristics as predicate devices	Stated in the "Substantial Equivalence" section.
Similar principles of operation as predicate devices	Stated in the "Substantial Equivalence" section.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size (e.g., number of potato slices, porcine muscle tissue samples, or individual tests). It states "potato slices and porcine muscle tissue" and "porcine liver, skin, and muscle tissue." This suggests an experimental setup but lacks quantification of samples.
Data Provenance: The data provenance is generally "bench testing." There is no mention of country of origin for the data or whether it was retrospective or prospective. Given it is bench testing, it would inherently be prospective for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of information is not applicable to the provided document. The study involved bench testing on inanimate and animal tissue to assess physical effects (vaporization, cutting, coagulation), not a clinical assessment requiring expert interpretation of ground truth in the human diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable. As a bench test comparing physical effects, there is no "adjudication method" in the sense of resolving discrepancies between human readers or experts. The comparison was based on performance and observed tissue effects, presumably by the researchers conducting the bench tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is an engineering bench test comparing a new laser system to a predicate laser system based on their physical interaction with tissue, not on diagnostic accuracy with human readers or AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This question is not applicable. The device is a surgical laser, not an AI algorithm. The performance evaluation was for the laser's physical capabilities (vaporization, cutting, coagulation) in a standalone manner (without a human in the loop for the performance measurement itself), but it's not an "algorithm" in the typical sense this question implies for AI/diagnostic devices.

7. The Type of Ground Truth Used

The "ground truth" for this study was the directly observed physical effects (vaporization, cutting, coagulation rates, and overall tissue effects) of the laser on standardized biological and non-biological materials (potato slices, porcine muscle, liver, and skin). The predicate device's performance served as the benchmark for "substantially equivalent" ground truth.

8. The Sample Size for the Training Set

Not applicable. This product is a physical laser device, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this type of device, no ground truth was established for a training set.

Summary

{0}------------------------------------------------

K072682

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}------------------------------------------------

K072682

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}------------------------------------------------

K072682

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}------------------------------------------------

K072682

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

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}------------------------------------------------

K072682

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

Regulation Number and Section

§ 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.