(90 days)
Not Found
No
The 510(k) summary describes a passive fiber optic cable for laser energy delivery and makes no mention of AI or ML.
Yes
The device is described as an accessory (fiber optic delivery system) for a laser used in lithotripsy procedures, which is a therapeutic intervention to break up stones in the body.
No
The device is described as a fiber optic delivery system used to deliver energy from a laser to a stone during lithotripsy procedures, which is a therapeutic function, not diagnostic.
No
The device description explicitly states it is a "disposable fiberoptic" and a "fiber optic delivery system," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "fiber optic delivery system" used "during lithotripsy procedures in the contact mode" to deliver energy to a stone. This is a therapeutic procedure performed on the patient's body, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description reinforces this by stating it's a "disposable fiberoptic which is designed to deliver energy... to the stone."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.
Product codes
GEX
Device Description
The Laser Fiber GF500 is a disposable fiberoptic which is designed to deliver energy from the W.O.M. Laser U100 to the stone in lithotripsy. The fiber which is provided non-sterile is available in 3,5 and 5 meter in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 device has been tested in accordance with the European Standard EN 554 and EN 1174. The Laser Fiber GF500 bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Laser Fiber GF100 (K011175), InnovaQuartz General Shape Laser Fiber (K994010)
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.
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AUG 2 0 2002
510(K) SUMMARY Laser Fiber GF500
I. Submitter:
W.O.M. WORLD OF MEDICINE AG Kaiserin-Augusta-Allee 113 10553 Berlin Germany
II. Device Names:
-
- Classification Name:
-
- Common or Usual Name:
-
- Proprietary Name:
Accessory to Laser Surgical Instrument Fiber Optic Delivery System Laser Fiber GF500
III. Classification:
Class II in accordance with 21 C.F.R. § 878.4810. The product code for the device is GEX.
IV. Predicate Devices:
- Laser Fiber GF100 (K011175), W.O.M. WORLD OF MEDICINE AG .
- InnovaQuartz General Shape Laser Fiber (K994010) manufactured by ● InnovaQuartz, Inc.
V. Intended Use:
The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.
VI. Device Description:
The Laser Fiber GF500 is a disposable fiberoptic which is designed to deliver energy from the W.O.M. Laser U100 to the stone in lithotripsy. The fiber which is provided non-sterile is available in 3,5 and 5 meter in length.
VII. Substantial Equivalence:
The Laser Fiber GF500 described in this notification is similar in design, material and technological characteristics to the Laser Fiber GF100 (K011175) of W.O.M. WORLD OF MEDICINE AG and the InnovaQuartz General Shape Laser Fiber (K994010) manufactured by InnovaQuartz, Inc.
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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text includes "KC21686" and "2022". The writing is somewhat stylized and has a slightly tilted orientation within the frame.
510(K) SUMMARY Page -2- / -2-
All three devices are intended to be used as a fiber optic delivery system for ND: Yag laser systems. In addition, both the Laser Fiber GF500 and the predicate device Laser Fiber GF100 are designed for use in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode. Finally, both the proposed device and the InnovaQuartz General Shape Laser Fiber are approved for reuse.
The differences between the Laser Faser GF500 and predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the Laser Fiber GF500 is substantially equivalent to the predicate devices currently on the market.
VIII. Performance Data:
The device has been tested in accordance with the European Standard EN 554 and EN 1174. The Laser Fiber GF500 bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.
Signed:
S. Reals
Susanne Raab Official Correspondent
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2002
W.O.M. World of Medicine c/o Šusanne Raab 91 Trowbridge Street Cambridge, Massachusetts 02138
Re: K021686 Trade/Device Name: Laser Fiber GF500 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in
dermatology Regulatory Class: Class II Product Code: GEX Dated: May 14, 2002 Received: May 22, 2002
Dear Ms. Raab:
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Susanne Raab
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" (21 CFR 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,
fo Mark N. Millerson
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
STATEMENT OF INDICATIONS FOR USE
WORLD OF MEDICINE Lemke GmbH
5
510(K) NUMBER (if known):
DEVICE NAME:
Laser Fiber GF500
09
INDICATIONS FOR USE:
The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
Prescription Use
Over-the Counter Ut
Mark N. Milliken
510(k) Number