(140 days)
No
The document describes accessory packs for ophthalmic microsurgical systems, consisting of reusable and single-use components like cassettes, tubing, and test chambers. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is described as an "accessory device" that facilitates the use of other microsurgical systems and handpieces during ophthalmic surgical procedures. It does not independently perform a therapeutic function.
No
The device is an accessory pack used for ophthalmic surgical procedures, specifically phacoemulsification and residual cortical material removal. It does not perform diagnostic functions.
No
The device description explicitly lists physical components such as collection cassettes, tubing sets, test chambers, needle wrench, and infusion sleeves, indicating it is a hardware device with accessories.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory for ophthalmic microsurgical systems used in surgical procedures (phacoemulsification and residual cortical material removal). This is a surgical device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details components like collection cassettes, tubing sets, test chambers, and handpieces, all of which are consistent with surgical equipment used during a procedure.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, providing diagnostic information, or any other activities typically associated with in vitro diagnostics.
Therefore, the Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are surgical accessory devices, not IVDs.
N/A
Intended Use / Indications for Use
The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.
The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack Contain replacement tubings, Venturi collection cassettes, needle sleeves, and tip testers for the Storz DAISY®, PREMIERE®, Protegé®, and Millennium™ Ophthalmic Microsurgical Systems and are used in anterior segment ophthalmic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
86HQC
Device Description
The Storz DP4210 Venturi Economy Anterior Pack is provided non-sterile and contains reusable components consisting of an anterior collection cassette, I/A tubing set, and I/A test chambers. The Storz DP5000 ASC Daypack is provided sterile and contains both reusable and single use components. The DP5000 reusable items include an anterior collection cassette, I/A test chambers, needle wrench, and infusion sleeve. The DP5000 single use items include an I/A tube assembly and a BSS administration tube assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior segment ophthalmic
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.
K854508, K894278, K921460, K946227, K921758, K950114, K961310, K935926, K951463
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/0 description: The image shows a sequence of characters that appear to be handwritten. The characters include 'K', 'G', '8', '0', '1', '0', and '0'. The characters are written in a dark color, possibly black ink, against a white background. The handwriting style is somewhat stylized, with distinct shapes for each character.
1 1998
Image /page/0/Picture/2 description: The image shows the word "storz" in white letters on a black background. The letters are stylized and have a unique font. There is a registered trademark symbol to the right of the word.
ﻣﺨﺘﻠﻔﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack Premarket Notification
-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. (314) 225-5051 STORZ, 3365 Tree Court Industrial Blvd., St. Louis, MO 63122-6694
Date Prepared: January 9, 1998.
Proprietary Name: Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack.
Common/Usual Name: Ophthalmic microsurgical system irrigation/aspiration and phacoemulsification accessory packs.
Classification Name: Unit, Phacofragmentation (86HQC).
Device Description/Intended Use: The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.
The Storz DP4210 Venturi Economy Anterior Pack is provided non-sterile and contains reusable components consisting of an anterior collection cassette, I/A tubing set, and I/A test chambers. The Storz DP5000 ASC Daypack is provided sterile and contains both reusable and single use components. The DP5000 reusable items include an anterior collection cassette, I/A test chambers, needle wrench, and infusion sleeve. The DP5000 single use items include an I/A tube assembly and a BSS administration tube assembly.
1
Predicate Device: The Storz DP4210 Venturi Economy Anterior Pack is substantially equivalent to the Storz DP4210 Universal I/A and Phaco Pack (K882240.) The Storz DP5000 ASC Daypack is substantially equivalent to the Storz DP4210 Universal I/A and Phaco Pack (K882240) and the Storz DP4310 Deluxe Phaco Pack (K955901.)
Predicate Comparison: A chart comparing the Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack to their respective predicate devices, demonstrating substantial equivalence, is attached.
Submitted by;
W. H. Johnson
Patrick G. Balsmann Regulatory Affairs Associate Storz Instrument Company
2
Storz DP4210 Venturi Economy Anterior Pack Device Comparison Chart
| Device Characteristic | Storz DP4210 (modified) | Storz DP4210 (existing) |
|---|---|---|
| 510(k): | Present. | Storz K882240. Referenced as accessory device in Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protegé® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. |
| Pack Name: | DP4210 Venturi Economy | |
| Anterior Pack | DP4210 Universal I/A and | |
| Phaco Pack | ||
| Intended Use: | Anterior segment irrigation/ | |
| aspiration and | ||
| phacoemulsification | ||
| ophthalmic surgical | ||
| procedures. | Anterior segment irrigation/ | |
| aspiration and | ||
| phacoemulsification | ||
| ophthalmic surgical | ||
| procedures. | ||
| Individual Pack | ||
| Components: | (1) Anterior | |
| Collection Cassette | ||
| (1) I/A Tubing Set | ||
| (2) I/A Test Chamber | (1) Anterior | |
| Collection Cassette | ||
| (1) I/A Tubing Set | ||
| (2) I/A Test Chamber | ||
| Anterior Collection | ||
| Cassette: | Cylindrical silicone reflux | |
| tube. | Rectangular silicone reflux | |
| tube. | ||
| Reusable Components: | Yes, all components. | Yes, all components. |
| Limited Reuse: | Not to exceed 20 times. | Not to exceed 20 times. |
| Pack Provided Sterile: | No. | No. |
·
ుర్త
3
Storz DP5000 ASC Daypack Device Comparison Chart
1
| Device
| Characteristic | Storz DP5000 | Storz DP4210 | Storz DP4310 |
|---|---|---|---|
| 510(k): | Referenced as accesory | ||
| device in Storz DAISY® | |||
| (K854508), PREMIERE® | |||
| (K894278, K921460 and | |||
| K946227), Protegé® | |||
| (K921758 and K950114), | |||
| and Millennium™ | |||
| (K961310) Ophthalmic | |||
| Microsurgical Systems. | |||
| Present. | Storz K882240. | Storz K955901. | |
| Pack Name: | DP5000 ASC Daypack. | DP4210 Universal I/A and | |
| Phaco Pack | DP4310 Deluxe Phaco | ||
| Pack. | |||
| Intended Use: | Anterior segment | ||
| irrigation/ | |||
| aspiration and | |||
| phacoemulsification | |||
| ophthalmic surgical | |||
| procedures. | Anterior segment | ||
| irrigation/ | |||
| aspiration and | |||
| phacoemulsification | |||
| ophthalmic surgical | |||
| procedures. | Anterior segment | ||
| irrigation/ | |||
| aspiration and | |||
| phacoemulsification | |||
| ophthalmic surgical | |||
| procedures. | |||
| Individual | |||
| Pack | |||
| Components: | (1) Anterior | ||
| Collection Cassette | |||
| (2) I/A Test Chamber | |||
| (1) Needle Wrench | |||
| (2) Infusion Sleeve | |||
| (1) I/A Tube Assembly | |||
| (1) BSS Administration | |||
| Tube Assembly | (1) Anterior | ||
| Collection Cassette | |||
| (1) I/A Tubing Set | |||
| (2) I/A Test Chamber | (1) Anterior | ||
| Collection Cassette | |||
| (2) I/A Test Chamber | |||
| (1) Needle Wrench | |||
| (2) Infusion Sleeve | |||
| (1) I/A Tube Assembly | |||
| (1) BSS Administration | |||
| Tube Assembly | |||
| (1) Auxiliary Drape | |||
| (1) Mayo Arm Drape | |||
| (1) Male Luer Cap | |||
| (1) Tube Stopper | |||
| Reusable | |||
| Components: | Yes, anterior collection | ||
| cassette, I/A test chamber, | |||
| needle wrench, and | |||
| infusion sleeve. | Yes, all components. | No. | |
| Limited Reuse | |||
| Components: | Not to exceed 10 times. | Not to exceed 20 times. | Not applicable. |
| Pack Provided | |||
| Sterile: | Yes. | No. | Yes. |
| Pack | |||
| Sterilization: | Not applicable. | Gamma irradiation. | Gamma irradiation. |
:
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1998
Mr. Gary M. Rauvola Group Manager, Bausch & Lomb Surgical, Storz Products 3365 Tree Court Industrial Blvd. St. Louis, MO 63122-6694
Re: K980100 Trade Name: Storz DP4210 Venturi Economy Anterior Pack and DP500 ASC Daypack Regulatory Class: II Product Code: 86 MSR Dated: April 24, 1998 Received: April 27, 1998
Dear Mr.Rauvola:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
5
Page 2 - Mr. Gary M. Rauvola
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page / of /
510(k) Number (if known): K 980100 Recess
Device Name: DR4211 Venture Frenchise Anterior Pack DP SCCC Indications For Use:
The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack The Storz Dr 4210 - Penian Loodlection cassettes, needle sleeves, and tip testers for Contain replacedore tabiligs, sents and Millennium™ Ophthalmic Microsurgical the Dioriz Dato, O, I reed in anterior segment ophthalmic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quynh Hoang
sion Sion-Off) Division of Ophthalmic Devices K980100 510(k) Number _
Prescription Use_ X (Per 21 CFR 801.109)
્ત્વ
Over-The-Counter Use_
(Optional Format 1-2-96)