(301 days)
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.
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.
This 510(k) summary describes Storz Ophthalmic Bipolar Cautery Instruments and Bipolar Cords (models D8200, D8201, D8203, D8202, D8204). The submission demonstrates substantial equivalence to predicate devices, thus no specific acceptance criteria or studies proving device performance are explicitly stated in the provided text.
The document focuses on comparing the new Storz devices to existing predicate devices (Kirwan Ophthalmic Bipolar Forceps, Pencils, and Cord; and Mentor WET-FIELD Bipolar Forceps and Bipolar Hemostatic Erasers) based on their intended use, material composition, system compatibility, connector type, reusability, and sterility.
Therefore, many of the requested details about acceptance criteria and studies cannot be extracted from this summary.
Here's a breakdown of what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided. The document does not list specific performance metrics (e.g., coagulation time, temperature thresholds, tissue damage limits) or acceptance criteria for those metrics. Instead, it relies on substantial equivalence to predicate devices. The "reported device performance" is implicitly that it functions similarly to the predicates for ophthalmic bipolar cautery.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a new clinical or performance study for the Storz devices themselves to establish novel performance claims. The comparison is based on the design and intended use relative to predicates.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The comparison is based on device specifications and intended use, not on expert-adjudicated ground truth data from testing.
4. Adjudication Method
Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not mentioned as it's not relevant for a substantial equivalence determination for this class of device based on the information provided.
6. Standalone Performance Study (Algorithm Only)
No. This device is a physical medical instrument (cautery devices and cords), not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable / Implicit. For substantial equivalence, the "ground truth" is that the predicate devices are legally marketed and safe/effective for their intended use. The Storz devices are considered substantially equivalent if they share similar technological characteristics and intended use.
8. Sample Size for the Training Set
Not applicable. This pertains to AI/ML models, not a physical medical device submission for substantial equivalence.
9. How Ground Truth for Training Set Was Established
Not applicable. See point 8.
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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. SwearingenRegulatory Affairs Associate |
|---|---|
| Date Prepared: | May 4, 1995 |
| Proprietary Name: | Storz Ophthalmic Bipolar Cautery Instruments and BipolarCords |
| 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.
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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 BipolarForceps | Kirwan Ophthalmic BipolarForceps | Mentor WET-FIELDOphthalmic 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-ContactMaterial Composition | Stainless steel | Stainless steel | Unknown |
| System for whichdevice is designed | Storz DAISY®, Protegé®,and PREMIERE®Ophthalmic MicrosurgicalSystems | Any compatible system | Mentor WET-FIELD IICoagulator |
| Connector type | Lemo™ locking connector | Two-pin plug | Two-pin plug |
| Reusable/Single Use?& | Reusable | Reusable and Single Usemodels | Single UseReusable (See Amendment) |
| Provided Sterile? | No | Reusable - NoSingle Use - Yes | Unknown |
| Manufacturer | Storz Instrument Company | Kirwan Surgical Products,Inc. | Mentor O & O, Inc. |
| Device | Storz Ophthalmic BipolarIntraocular Diathermy | Kirwan Ophthalmic BipolarPencils | 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, 20gauge | 14-5004/14-7006 - gradualtaper, sharp tip, 20 gauge;14-5006/14-7008 - steeptaper, sharp tip, 23 gauge | 22-1260 - gradual taper, sharptip, 20 gauge;22-1265 - steep taper, sharptip, 23 gauge |
| Patient-ContactMaterial Composition | Stainless steel outer electrode,Spring steel inner electrode,Liquid crystal polymerinsulation | Stainless steel; othermaterials unknown | Unknown |
| System for whichdevice is designed | Storz DAISY®, Protege®, andPREMIERE® OphthalmicMicrosurgical 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 - SingleUse,14-7006/14-7008 - Reusable | Single Use |
| Provided Sterile? | No | Single Use - YesReusable - No | Yes |
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D8203 Substantial Equivalence Comparison
1-512_5571
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| Manufacturer | Storz Instrument Company | Kirwan Surgical Products, Inc. |
|---|---|---|
| Device | D8202 and D8204 Storz OphthalmicBipolar Cords | Kirwan Model 10-6010 BipolarCord |
| Intended Use | D8202 - To connect D8200, D8201,D8203 cautery instruments to StorzDAISY Microsurgical SystemD8204 - To connect D8200, D8201,D8203 to Storz Protege andPREMIERE Microsurgical Systems | Connects cautery instruments tocompatible coagulator system |
| Connector Type | Lemo™ Locking connectors on bothends of cords | Lemo™ locking connector tocoagulator system;Two-pin plug to instrument |
| Reusable/Single Use? | Reusable | Reusable |
| Provided Sterile? | No | No |
| Cord insulationmaterial/size | Thermoplastic rubber/ Six feet long | Silicone/ twelve feet long |
D8202/D8204 Substantial Equivalence Comparison
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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.