(140 days)
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 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.
This document is a 510(k) premarket notification for two ophthalmic accessory packs, the Storz DP4210 Venturi Economy Anterior Pack and the Storz DP5000 ASC Daypack. It focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a study with performance metrics.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because this type of 510(k) submission generally relies on demonstrating similarity to legally marketed devices, not on new clinical performance studies with defined acceptance criteria and statistical analysis as would be required for a novel device or a Premarket Approval (PMA) application.
Here's what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices, not to present performance metrics against predefined acceptance criteria. The "performance" is implicitly deemed equivalent to the predicate devices if substantial equivalence is established.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document | Not provided in the document |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This is a 510(k) premarket notification for accessory packs, which typically does not involve a "test set" and performance data in the way a clinical study for a drug or novel device would. The assessment is based on comparing device characteristics and intended use to predicate devices. There is no mention of a clinical study or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No "ground truth" establishment by experts for a test set is mentioned, as this is not a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. MRMC studies are not relevant to this type of device and submission. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device does not involve algorithms or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth determination is described.
8. The sample size for the training set
- Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set or ground truth establishment relevant to this context is described.
Summary of what the document does provide in relation to regulatory acceptance:
The document outlines a process of demonstrating substantial equivalence to existing legally marketed predicate devices, which is the "acceptance criteria" for a 510(k) submission.
- Predicate Devices:
- Method of "Proof": Device comparison charts (Pages 2-3) are used to highlight similarities in:
- 510(k) reference (i.e., previous clearance)
- Pack Name
- Intended Use
- Individual Pack Components
- Anterior Collection Cassette design (for DP4210 comparison)
- Reusable Components
- Limited Reuse (number of times)
- Pack Provided Sterile (Yes/No)
- Pack Sterilization method (for DP5000 comparison)
- Result of "Study" (FDA Outcome): The FDA reviewed the 510(k) notification and determined the device (both packs) to be substantially equivalent for its stated indications for use (Page 4). This determination allows the device to be marketed.
This document serves as an example of a 510(k) submission where "acceptance criteria" and "study" are framed by the regulatory concept of substantial equivalence, rather than a clinical trial with specific performance endpoints.
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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.
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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
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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 EconomyAnterior Pack | DP4210 Universal I/A andPhaco Pack |
| Intended Use: | Anterior segment irrigation/aspiration andphacoemulsificationophthalmic surgicalprocedures. | Anterior segment irrigation/aspiration andphacoemulsificationophthalmic surgicalprocedures. |
| Individual PackComponents: | (1) AnteriorCollection Cassette(1) I/A Tubing Set(2) I/A Test Chamber | (1) AnteriorCollection Cassette(1) I/A Tubing Set(2) I/A Test Chamber |
| Anterior CollectionCassette: | Cylindrical silicone refluxtube. | Rectangular silicone refluxtube. |
| 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
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Storz DP5000 ASC Daypack Device Comparison Chart
1
| DeviceCharacteristic | Storz DP5000 | Storz DP4210 | Storz DP4310 |
|---|---|---|---|
| 510(k): | Referenced as accesorydevice in Storz DAISY®(K854508), PREMIERE®(K894278, K921460 andK946227), Protegé®(K921758 and K950114),and Millennium™(K961310) OphthalmicMicrosurgical Systems.Present. | Storz K882240. | Storz K955901. |
| Pack Name: | DP5000 ASC Daypack. | DP4210 Universal I/A andPhaco Pack | DP4310 Deluxe PhacoPack. |
| Intended Use: | Anterior segmentirrigation/aspiration andphacoemulsificationophthalmic surgicalprocedures. | Anterior segmentirrigation/aspiration andphacoemulsificationophthalmic surgicalprocedures. | Anterior segmentirrigation/aspiration andphacoemulsificationophthalmic surgicalprocedures. |
| IndividualPackComponents: | (1) AnteriorCollection Cassette(2) I/A Test Chamber(1) Needle Wrench(2) Infusion Sleeve(1) I/A Tube Assembly(1) BSS AdministrationTube Assembly | (1) AnteriorCollection Cassette(1) I/A Tubing Set(2) I/A Test Chamber | (1) AnteriorCollection Cassette(2) I/A Test Chamber(1) Needle Wrench(2) Infusion Sleeve(1) I/A Tube Assembly(1) BSS AdministrationTube Assembly(1) Auxiliary Drape(1) Mayo Arm Drape(1) Male Luer Cap(1) Tube Stopper |
| ReusableComponents: | Yes, anterior collectioncassette, I/A test chamber,needle wrench, andinfusion sleeve. | Yes, all components. | No. |
| Limited ReuseComponents: | Not to exceed 10 times. | Not to exceed 20 times. | Not applicable. |
| Pack ProvidedSterile: | Yes. | No. | Yes. |
| PackSterilization: | Not applicable. | Gamma irradiation. | Gamma irradiation. |
:
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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 .
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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
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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)
§ 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.