(341 days)
K 915236
Not Found
No
The description focuses on a laser delivery system and its mechanical application, with no mention of AI/ML terms or functionalities like image processing, data analysis, or automated decision-making based on algorithms.
Yes
The device is explicitly stated to be used to reduce intraocular pressure associated with Glaucoma, which is a treatment for an eye disease.
No
Explanation: The device is described as a "laser delivery system" used to "reduce the intraocular pressure" to treat glaucoma, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "laser delivery system" and a "contact probe," indicating it is a physical hardware component used in conjunction with a laser.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the CPC Probe is a laser delivery system used in conjunction with a laser to treat glaucoma by reducing intraocular pressure. It is applied directly to the eye (sclera) and delivers energy to the tissue.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a therapeutic device, not a diagnostic one.
Therefore, based on the provided information, the Zeiss CPC Probe is a therapeutic ophthalmic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma. The contact probe is applied with slight pressure to the sclera and located approximately 1.5 mm behind the limbus. This method significantly increases the transmission of the sclera and also reduces the scattering of the laser beam. The power is adjusted and increased successively until the proper effect is heard. The power is then reduced and remaining coagulations can be performed if needed.
This device will be used in the same manner as the device mentioned above and will permit the Zeiss Visulas Diode II to be further utilized as a therapeutic ophthalmic laser. It incorporates the same intended uses as the Iris Medical G Probe and specifically is recommended for treating the following eye disease: Glaucoma.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. The Zeiss CPC Probe is substantially equivalent to the Iris Medical G Probe in that both are used to permit the individual companies laser to deliver impulses that photocoagulate the ciliary body of the eye in patients that are diagnosed with Glaucoma, thereby reducing the patient's intraocular pressure which slows the progress of the disease. The only differences between the two delivery units are: The approximate amount of times the contact tips can be sterilized, the material the tips are made of and slight differences in the power range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ciliary body of the eye
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 915236
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 1 7 1997
Pursuant to 21 CFR 807.92 the following summary is submitted.
- Submitter's name-Carl Zeiss, Inc. 1 Zeiss Drive Thornwood, NY 10594 (914) 681-7761 Contact Person-Kenneth M. Nicoll April 4, 1996
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- Zeiss CPC Probe Laser Probe
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We are claiming substantial equivalence to the Iris Medical G-Probe, K 915236.
-
The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma. The contact probe is applied with slight pressure to the sclera and located approximately 1.5 mm behind the limbus. This method significantly increases the transmission of the sclera and also reduces the scattering of the laser beam. The power is adjusted and increased successively until the proper effect is heard. The power is then reduced and remaining coagulations can be performed if needed.
-
This device will be used in the same manner as the device mentioned above and will permit the Zeiss Visulas Diode II to be further utilized as a therapeutic ophthalmic laser. It incorporates the same intended uses as the Iris Medical G Probe and specifically is recommended for treating the following eye disease: Glaucoma.
-
The Zeiss CPC Probe is substantially equivalent to the Iris Medical G Probe in that both are used to permit the individual companies laser to deliver impulses that photocoagulate the ciliary body of the eye in patients that are diagnosed with Glaucoma, thereby reducing the patient's intraocular pressure which slows the progress of the disease. The only differences between the two delivery units are: The approximate amount of times the contact tips can be sterilized, the material the tips are made of and slight differences in the power range.