(90 days)
Not Found
No
The document describes a fiber optic laser delivery system and its intended uses and does not mention any AI or ML components or capabilities.
Yes
The device is described as a fiber optic laser delivery system intended for vaporization, cutting, ablation, and coagulation of soft tissue in various medical and surgical specialties. These are therapeutic actions performed directly on the patient's body.
No
The device description and intended use clearly state that it is a surgical tool used for vaporization, cutting, ablation, and coagulation of soft tissue, not for diagnosis.
No
The device description clearly states it is a fiber optic laser delivery system consisting of a physical fiber, cladding, buffer, and shaped tip, which are hardware components.
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 for diagnosis, monitoring, or screening.
- Device Function: The Wave Form Manufacturing Prolase General Shaped Fiber is a laser delivery system used for surgical procedures on soft tissue within the body (vaporization, cutting, ablation, coagulation). It is used in conjunction with or without endoscopic equipment or for open surgery.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens taken from the patient. Its function is directly on the tissue itself.
Therefore, the device's intended use and description clearly indicate it is a surgical tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, ureteroscopes, bronchoscopes, cystoscopes, gastroscopes, arthroscopes, colonoscopes, or for open surgery in contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Wave Form Manufacturing PGS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Podiatry, Orthopedics, Lithotripsy, ENT Surgery, Neurosurgery, Gastroenterology, Plastic Surgery, Dermatology, Radiology, Gynecology, and General and Vascular Surgery.
Product codes
GEX
Device Description
The Wave Form Manufacturing Prolase General Shaped (PGS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the PGS fiber may be used for a wide variety of surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, including areas relevant to Urology, Pulmonology, Arthroscopy, Podiatry, Orthopedics, Lithotripsy, ENT Surgery, Neurosurgery, Gastroenterology, Plastic Surgery, Dermatology, Radiology, Gynecology, and General and Vascular Surgery.
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 demonstrate that the device will perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K954904, K994010, K001243, K990947
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
MAY 3 0 2002
CD20673 ATTACHMENT 6 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Wave Form Manufacturing Prolase General Shaped Fiber
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Wave Form Manufacturing, Inc. 8095 SW Nimbus Ave, Bldg. 12 Beaverton, Oregon 97008 Contact: Charles R. Watkins
Phone: 800-332-8749 Facsimile: 503-643-6314 Email: chuckw@waveformsys.com Date Prepared: February 28, 2002
Name of Device and Name/Address of Sponsor
Trade Name: Wave Form Manufacturing Prolase General Shaped Fiber Classification Name: Laser Surgical Instrument Accessories
Predicate Devices
InnovaQuartz General Shaped Fiber (K954904), single use InnovaQuartz General Shaped Fiber (K994010), reuse Dornier Medilas H Fibers (K001243) Lumenis Slimline Fibers (K990947)
Device Description
The Wave Form Manufacturing Prolase General Shaped (PGS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the PGS fiber may be used for a wide variety of surgical procedures.
Indications for Use
The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, ureteroscopes, bronchoscopes, cystoscopes, gastroscopes, arthroscopes, colonoscopes, or for open surgery in contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Wave Form Manufacturing PGS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Pulmonology, Arthroscopy, Podiatry, Orthopedics, Lithotripsy, ENT Surgery, Neurosurgery, Gastroenterology, Plastic Surgery, Dermatology, Radiology, Gynecology, and General and Vascular Surgery.
1
Technological Characteristics and Performance Data
Design changes made to the Wave Form Manufacturing PGS Fiber are the addition of an internal proprietary quartz sleeve reflector which protects the laser focusing lens from back splatter of vaporized metal from the connector ferrule and the addition of an optical secondary memory cladding to help guide a steerable endoscope with the optical fiber.
Bench testing was performed to demonstrate that the device will perform as intended.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wave Form Manufacturing, Inc. c/o Mr. Joe Brown Optical Integrity 8317 Front Beach Road Panama City Beach, FL 32407
MAY 3 0 2002
Re: K020673
R02007-5
Trade/Device Name: Wave Form Manufacturing Prolase General Shaped Fibers Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 28, 2002 Received: March 1, 2002
Dear Mr. Brown:
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 for associated in the 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). and Cosmotion (110) that the device, subject to the general controls provisions of the Act. The I ou may , and controls 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 If your de roo is exach 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 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.
3
Page 2 – Mr. Joe Brown
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Por Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number: 020673
Device Name: Wave Form Manufacturing Prolase General Shaped Fibers
Indications for Use:
The Wave Form Manufacturing Prolase General Shaped Fiber is intended to be used in vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, bronchoscopes, cystoscopes, ureteroscopes, gastroscopes and colonoscopes, or for contact or non-contact surgery with or without handpiece for use in coagulation, incision/excision, ablation and vaporization of soft tissue.
The Wave Form Manufacturing Prolase General Shaped Fiber is indicated for use in medicine and surgery in the following medical specialties:
-
Urology
-
Plastic Surgery ●
-
Radiology .
-
Dermatology .
-
Pulmonolgy .
-
Gastroenterology ●
-
Gynecology ●
-
General and Vascular Surgery .
Lithotripsy -
Arthroscopy ●
-
Podiatry .
.
Association
-
Orthopedics
-
Neurosurgery
-
Plastic Surgery
-
ENT
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use
Or
Over-the-Counter Use
usiam C. Provost
n of General, Restorative and Neurological Devices
510(k) Number K620673