(301 days)
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No
The document describes standard bipolar cautery devices and their accessories, with no mention of AI or ML capabilities in the intended use, device description, or any other section.
No
The device is used to control bleeding during surgical procedures by coagulating tissue; it is not a therapeutic device designed for treatment or diagnosis of a condition or disease.
No
The device is described as being used to control bleeding and cauterize vessels during ophthalmic surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical hardware components (forceps, erasers, cords) made of materials like stainless steel and polymer, which are accessories to larger surgical systems. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. This is a therapeutic and surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details surgical instruments (forceps, erasers, cords) used directly on tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, 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 does not fit that description.
N/A
Intended Use / Indications for Use
The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.
Product codes (comma separated list FDA assigned to the subject device)
HQR
Device Description
Storz D8200 series Ophthalmic Bipolar Cautery devices are accessories to Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems. The D8200 is a reusable bipolar forceps, D8201 is a reusable bipolar eraser, and the D8203 is a reusable bipolar intraocular eraser. The D8202 bipolar cord is used to connect the three cautery instruments to the Storz DAISY® Microsurgical System; the D8204 bipolar cord is used to connect the three cautery instruments to the Storz Protege® and PREMIERE® Microsurgical Systems. All three instruments and both cords have Lemo™ locking connectors. The D8200 forceps are composed of surgical grade stainless steel; the D8201 and D8203 erasers are composed of surgical grade stainless steel and spring steel, and liguid crystal polymer insulation. These materials raise no questions of biocompatibility.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Extraocular tissue; vessels internal to the eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
The Kirwan Ophthalmic Bipolar Forceps, Bipolar Pencils, and Bipolar Predicate Devices: Cord (Kirwan Surgical Products, Inc.); and Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers (Mentor O & O, Inc.).
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.
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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).
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§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.
0
KG52151
Image /page/0/Picture/1 description: The image shows the word "storz" in white letters against a black background. The letters are stylized and bold. The word is centered in the image and appears to be a logo or brand name.
510(k) Summary of Safety and Effectiveness
MAR - 4 1996
The following information is submitted in accordance with 21 CFR 807.92:
Submitted by:
Audrey L. Swearingen
Audrey G. Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 314/225-5051
| Contact Person: | Audrey G. Swearingen
Regulatory Affairs Associate |
|----------------------|-------------------------------------------------------------------|
| Date Prepared: | May 4, 1995 |
| Proprietary Name: | Storz Ophthalmic Bipolar Cautery Instruments and Bipolar
Cords |
| Common/Usual Name: | Ophthalmic Bipolar Cautery Devices |
| Classification Name: | Apparatus, Cautery, Radiofrequency, AC powered; 86(HQR) |
Device Description: Storz D8200 series Ophthalmic Bipolar Cautery devices are accessories to Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems. The D8200 is a reusable bipolar forceps, D8201 is a reusable bipolar eraser, and the D8203 is a reusable bipolar intraocular eraser. The D8202 bipolar cord is used to connect the three cautery instruments to the Storz DAISY® Microsurgical System; the D8204 bipolar cord is used to connect the three cautery instruments to the Storz Protege® and PREMIERE® Microsurgical Systems. All three instruments and both cords have Lemo™ locking connectors. The D8200 forceps are composed of surgical grade stainless steel; the D8201 and D8203 erasers are composed of surgical grade stainless steel and spring steel, and liguid crystal polymer insulation. These materials raise no questions of biocompatibility.
Intended Use: The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.
1
The Kirwan Ophthalmic Bipolar Forceps, Bipolar Pencils, and Bipolar Predicate Devices: Cord (Kirwan Surgical Products, Inc.); and Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers (Mentor O & O, Inc.).
Predicate Comparison: Tables comparing the Storz Ophthalmic Bipolar Cautery devices to predicate devices, demonstrating substantial equivalence, are attached.
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| Manufacturer | Storz Instrument Company | Kirwan Surgical Products,
Inc. | Mentor O & O, Inc. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Device | Storz Ophthalmic Bipolar
Forceps | Kirwan Ophthalmic Bipolar
Forceps | Mentor WET-FIELD
Ophthalmic Forceps |
| Model(s) | Model D8200 | Several models | Models 22-1204,
22-1206, 22-1207, and 22-
1209 |
| Intended Use | Extraocular cauterization | Extraocular cauterization | Extraocular cauterization |
| Patient-Contact
Material Composition | Stainless steel | Stainless steel | Unknown |
| System for which
device is designed | Storz DAISY®, Protegé®,
and PREMIERE®
Ophthalmic Microsurgical
Systems | Any compatible system | Mentor WET-FIELD II
Coagulator |
| Connector type | Lemo™ locking connector | Two-pin plug | Two-pin plug |
| Reusable/Single Use?
& | Reusable | Reusable and Single Use
models | Single Use
Reusable (See Amendment) |
| Provided Sterile? | No | Reusable - No
Single Use - Yes | Unknown |
| Manufacturer | Storz Instrument Company | Kirwan Surgical Products,
Inc. | Mentor O & O, Inc. |
| Device | Storz Ophthalmic Bipolar
Intraocular Diathermy | Kirwan Ophthalmic Bipolar
Pencils | Mentor WET-FIELD II®
Ophthalmic Hemostatic Erasers |
| Model(s) | Model D8203 | Models 14-5004, 14-5006,
14-7006, and 14-7008 | Models 22-1260, 22-1265 |
| Intended Use | Intraocular cauterization | Intraocular cauterization | Intraocular cauterization |
| Tip Configuration | Steep taper, sharp tip, 20
gauge | 14-5004/14-7006 - gradual
taper, sharp tip, 20 gauge;
14-5006/14-7008 - steep
taper, sharp tip, 23 gauge | 22-1260 - gradual taper, sharp
tip, 20 gauge;
22-1265 - steep taper, sharp
tip, 23 gauge |
| Patient-Contact
Material Composition | Stainless steel outer electrode,
Spring steel inner electrode,
Liquid crystal polymer
insulation | Stainless steel; other
materials unknown | Unknown |
| System for which
device is designed | Storz DAISY®, Protege®, and
PREMIERE® Ophthalmic
Microsurgical Systems | Any compatible system | Mentor WET-FIELD II®
Coagulator |
| Connector Type | Lemo™ locking connector | Two-pin plug | Two-pin plug |
| Reusable/Single Use? | Reusable | 14-5004/14-5006 - Single
Use,
14-7006/14-7008 - Reusable | Single Use |
| Provided Sterile? | No | Single Use - Yes
Reusable - No | Yes |
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D8203 Substantial Equivalence Comparison
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| Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. |
|---|---|---|
| Device | D8202 and D8204 Storz Ophthalmic | |
| Bipolar Cords | Kirwan Model 10-6010 Bipolar | |
| Cord | ||
| Intended Use | D8202 - To connect D8200, D8201, | |
| D8203 cautery instruments to Storz | ||
| DAISY Microsurgical System | ||
| D8204 - To connect D8200, D8201, | ||
| D8203 to Storz Protege and | ||
| PREMIERE Microsurgical Systems | Connects cautery instruments to | |
| compatible coagulator system | ||
| Connector Type | Lemo™ Locking connectors on both | |
| ends of cords | Lemo™ locking connector to | |
| coagulator system; | ||
| Two-pin plug to instrument | ||
| Reusable/Single Use? | Reusable | Reusable |
| Provided Sterile? | No | No |
| Cord insulation | ||
| material/size | Thermoplastic rubber/ Six feet long | Silicone/ twelve feet long |
D8202/D8204 Substantial Equivalence Comparison
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