(69 days)
Not Found
No
The description focuses on a mechanical adaptor for surgical instruments and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The device is an adaptor for surgical instruments, facilitating their connection, rather than directly diagnosing, treating, or preventing a disease.
No
The device is an accessory designed to adapt surgical instruments. Its function is mechanical (connecting existing parts) and does not involve detecting, monitoring, or predicting medical conditions or diseases.
No
The device description explicitly states the device is composed of stainless steel and is a physical adaptor, indicating it is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general use in posterior segment vitreoretinal ophthalmic surgery." This describes a surgical instrument accessory used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a mechanical adaptor made of stainless steel for connecting surgical instruments. This aligns with a surgical device accessory, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed 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 E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTecTM Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
86HQE
Device Description
The Storz E8010 ErgoTec™/Premiere® Adaptor is composed of stainless steel and serves to allow connection of the existing Storz D7108 Microscissors Handpiece to the existing Storz ErgoTecTM Vitreoretinal Instrument Tips. An illustration of the the Storz E8010 ErgoTec™/Premiere® Adaptor is included in the device instructions which are attached.
The Storz E8010 ErgoTec * /Premiere® Adaptor allows the ErgoTec * Vitreoretinal Instrument System tips to be used with the Storz D7108 Microscissors Handpiece. The adaptor features an anterior rotation knob which allows the tip to be adjusted into optimal alignment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior intraocular tissue.
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.
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
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/1 description: The image shows the word "storz" in white letters against a black background. The font is bold and sans-serif. The letters are slightly distressed, giving the image a vintage or worn look.
Premarket Notification Storz Instrument Company
964743
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR § 807.92:
Contact Person: Patrick G. Balsmann, Regulatory Affairs Associate Storz, 3365 Tree Court Industrial Bldv., St. Louis, MO 63122-6694 Phone: (314) 225- 5051, ext. 5538.
Date Prepared: January 9, 1997.
Proprietary Name: Storz E8010 ErgoTecTM/Premiere® Adaptor.
Common/Usual Name: Adaptor for ophthalmic microscissors driver handpiece and interchangeabe instrument tips.
Classification Name: Instrument, vitreous cutting and aspirating (86HQE).
Device Description/Intended Use: The Storz E8010 ErgoTec™/Premiere® Adaptor is a new device accessory designed to adapt the Storz ErgoTecTM Vitreoretinal Instrument Tips to the Storz D7108 Microscissors Handpiece for general use in posterior segment vitreoretinal ophthalmic surgery. The Storz E8010 ErgoTec™/Premiere® Adaptor is composed of stainless steel and serves to allow connection of the existing Storz D7108 Microscissors Handpiece to the existing Storz ErgoTecTM Vitreoretinal Instrument Tips. An illustration of the the Storz E8010 ErgoTec™/Premiere® Adaptor is included in the device instructions which are attached.
Predicate Device: The Storz D7108 Microscissors Handpiece, as it utilizes the new Storz E8010 ErgoTec™/Premiere® Adaptor and Storz ErgoTec Instrument Tips, is similar in design, function, and composition to the Storz CX7100 and CX7150 Microscissors Handpieces (K961310) and the existing Storz Microscissors Handpiece (K960061).
Predicate Comparison: A chart comparing characteristics of the Storz D7108 Microscissors Handpiece, as it utilizes the new Storz E8010 ErgoTecTMPremiere® Adaptor and Storz ErgoTec Instrument Tips, to those of the predicate devices, is attached.
Submitted by:
Patrick G. Balsmann Regulatory Affairs
STORZ® INSTRUMENT COMPANY, 3365 Tree Court Industrial Blvd., St. Louis, MO 63122-6694 (314) 225-5051 FAX (314) 225-7365
1
Image /page/1/Figure/0 description: The image shows the logo and contact information for Storz Instrument Company. The logo is on the left side of the image, and the address is St. Louis, MO 63122-6694. On the right side of the image, the text "ErgaTec™/Premiere® Adapter - E8010 User Instructions" is present. The image appears to be from a user manual or product information sheet.
Image /page/1/Figure/1 description: The image shows three separate components of a surgical instrument. The first component is the ErgoTec Tip Assembly, which includes a protective tip guard. The second component is the ErgoTec Adapter E8010. The third component is the Scissor Handpiece D7108.
The Storz E8010 ErgoTec * /Premiere® Adaptor allows the ErgoTec * Vitreoretinal Instrument System tips to be used with the Storz D7108 Microscissors Handpiece. The adaptor features an anterior rotation knob which allows the tip to be adjusted into optimal alignment.
- NOTE: Refer to the Premiere® Microsurgical System owner's manual for instructions on use of the Storz D7108 Microscissors Handpiece.
Preparation for Use
- A. Hold the handpiece firmly and thread the adaptor to the handpiece by grasping the posterior end of the adaptor and turning it clockwise onto the handpiece until secure.
- B. With the plastic protective tip guard in place, hold the rotation knob of the adaptor firmly and securely attach the tip to the adaptor/handpiece assembly by threading the tip clockwise onto the assembly.
- C. Remove the protective tip guard by grasping the guard at the tip end and pulling it downward from the lip toward the adaptor/ handpiece assembly.
Disassembly of Instrument
- A. Reinstall the protective tip guard in opposite manner of removal. Hold the rotation inob of the adaptor firmly and unscrew the tip by turning counterclockwise being careful to protect the tip from damage.
- B. Hold the handplece firmly and unscrew the adaptor by grasping the posterior end and turning countercolckwise.
Cleaning and Sterilization Instructions
- A. For the ErgoTec ™ Tip, follow the cleaning and sterilization which came with the tip.
- The adaptor should be removed from the handpiece for cleaning. 8.
- C. Clean outer surfaces with mild detergent solution and water.
-
- Thoroughty rinse with warm (30-40°C) distilled or deignized water.
- E. The adaptor should be installed on the handpiece for sterilization.
The minimum requirements for sterilization are:
- Standard Gravity Steam Sterilization (Preferred method). Place the handpiece in a . clean open tray, wrapped or unwrapped. Sterilize for 30 minutes at 121° C. (250° F.).
- . Flash Sterilization. Place the unwrapped handpiece in a clean open tray. Sterifize for 10 minutes at 132° C. (270° F.).
- High Vacuum Sterilization. Place the wrapped handpiece in a clean open tray. . Sterilize for a minimum of 3 minutes at 134° C. -01+3°
CAUTION: Allow the adapter/handpiece assembly to cool at least 20 minutes before handling.
039005451 Rev. A
Plastic Protective
Tip Guard
2
K964743
Storz E8010 ErgoTec™/Premiere® Adaptor Device Comparison Chart
| Device Characteristic | Storz D7108 Microscissor HP (with new
Storz ErgoTec™/Premiere® Adaptor) | Storz D7108 Microscissor HP (without
Storz ErgoTec™/Premiere® Adaptor) | Storz CX7100 & CX7150
Microscissors HP's |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | Current. K964743 | # K960061 | # K961310 |
| Intended Use | Cutting and manipulation of posterior
intraocular tissue. | Cutting and manipulation of posterior
intraocular tissue. | Cutting and manipulation of posterior
intraocular tissue. |
| Recommended
Microsurgical System | Storz Premiere® Microsurgical System. | Storz Premiere® Microsurgical System. | Storz Millennium™ Microsurgical System. |
| System Components | Storz D7108 Microscissor Handpiece;
Storz D7106 Microscissor Drive Tube;
Storz E8010 ErgoTec™/Premiere®
Adaptor;
Storz ErgoTec™ Vitreoretinal Instrument
Tips. | Storz D7108 Microscissor Handpiece:
Storz D7106 Microscissor Drive Tube:
Grieshaber Microscissors Tips. | Storz CX7100 Vertical Cut Handpiece;
Storz CX7150 Proportional Cut
Handpiece;
Storz ErgoTec™ Vitreoretinal Instrument
Tips. |
| Microscissor Activation
Mechanism | Pneumatic. | Pneumatic. | Electrical. |
| Detachable Tips? | Yes. | Yes. | Yes. |
| Rotatable Tips? | Yes. | Yes. | Yes. |
| Reusable Tips? | Yes. | Yes. | Yes. |
| Tip Materials? | 420 Stainless steel. | Stainless steel. | 420 Stainless steel. |
| Compatible With Single
& Multi-Cut Modes? | Yes. | Yes. | Yes. |
| Footpedal Control? | Yes. | Yes. | Yes. |
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