(15 days)
The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones and upper ureteral stones.
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The provided text is a 510(k) summary for the Dornier Lithotripter 140, which is a medical device for fragmenting urinary tract stones. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a full clinical study with detailed statistical analysis as would be done for an AI/ML diagnostic device.
Therefore, many of the requested categories for AI/ML device studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) are not applicable to this 510(k) summary for a lithotripter.
However, I can extract the relevant information based on what is available in the document.
Acceptance Criteria and Device Performance for Dornier Lithotripter 140
As this is a 510(k) submission for a physical medical device (lithotripter), the "acceptance criteria" are not reported as quantitative performance metrics (like sensitivity/specificity for AI models) but rather as the device's functional equivalence and safety compared to predicate devices. The study proving this typically involves demonstrating that the new device's technological characteristics and overall performance are substantially equivalent to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criterion (Implied) | Reported Device Performance (Dornier Lithotripter 140) |
|---|---|---|
| Intended Use | Same as predicate devices | Indicated for fragmentation of urinary tract stones (renal calyceal, renal pelvic, and upper ureteral stones), which is the same as the predicate devices. |
| Technological Characteristics | Substantially equivalent to predicate devices with no significant differences that raise safety/effectiveness concerns | The submitter states that "the Dornier Lithotripter 140 ("Doli 140") and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Medical Systems, Inc. believes that no significant differences exist between the Dornier Lithotripter 140 ("Doli 140") and the predicate devices." |
| Overall Performance | Substantially equivalent to predicate devices with no significant differences that raise safety/effectiveness concerns | The submitter states that "the Dornier Lithotripter 140 ("Doli 140") and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Medical Systems, Inc. believes that no significant differences exist between the Dornier Lithotripter 140 ("Doli 140") and the predicate devices." |
| Safety and Effectiveness | Demonstrated to be safe and effective, similar to predicate devices. | The safety and effectiveness are based on a determination of substantial equivalence to the predicate devices. The minor differences are believed to "not raise any concerns regarding the overall safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a 510(k) for a physical medical device, not a data-driven AI/ML device requiring a test set of data. The submission relies on comparison of design specifications and technological characteristics to predicate devices.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable. This type of submission typically involves engineering and clinical review of device specifications and clinical indications, rather than expert-based ground truth for a diagnostic output.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, an MRMC study was not done. This is a physical lithotripter, not an AI-assisted diagnostic device for human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance (PMA or 510(k)). The substantial equivalence argument relies on the assumption that if the new device is sufficiently similar, it will also be safe and effective for the stated indications.
8. The sample size for the training set
- Sample Size: Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
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JUN 2 2 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Medical Systems, Inc.'s Dornier Lithotripter 140
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Dornier Lithotripter 140 ("Doli 140")is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices, which includes the following:) Dornier Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Dornier Medical Systems, Inc.1155 Roberts BoulevardKennesaw, GA 30144 | Phone: | 770-426-1315 |
|---|---|---|
| Facsimile: | 770-514-6288 | |
| Date Prepared: | June 5, 2001 | |
| Contact Person: Suzanne Courtney | Phone: | 770-514-6206 |
| Fax: | 770-514-6288 |
Name of Device and Name/Address of Sponsor
Dornier Lithotripter 140 ("Doli 140") Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw, GA 30144
Classification Name
According to 21 CFR § 876.5990, FDA has classified extracorporeal shock wave lithotripters as Class II device with special controls. The Product Code for these lithotripters is 78 LNS..
Predicate Devices
Dornier Compact Alpha Lithotripter (K002929) Dornier Compact Delta Lithotripter (P840008 / S65)
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Intended Use
K011773
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The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones and upper ureteral stones.
Technological Characteristics and Substantial Equivalence
From a clinical perspective and comparing design specifications, the Dornier Lithotripter 140 ("Doli 140") and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Medical Systems, Inc. believes that no significant differences exist between the Dornier Lithotripter 140 ("Doli 140") and the predicate devices, Dornier Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65).
Dornier Medical Systems, Inc. believes the minor differences of the Dornier Lithotripter 140 ("Doli 140") and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.
- This information was prepared for the sole purpose of compliance Advisory: with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2001
Ms. Suzanne Courtney Manager, Regulatory and Quality Affairs Dornier Medical Systems, Incorporated 1155 Roberts Boulevard KENNESAW GA 30144
Re: K011773 Dornier Lithotripter 140 ("Doli 140") Dated: June 5, 2001 Received: June 7, 2001 Regulatory Class: II 21 CFR §876.5990/Procode: 78 LNS
Dear Ms. Courtney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Section 310(x) notherions of mich evelosure) to legally marketed predicate devices device is substantially equivality tot the mactions 16, 1976, the enactment date of the Medical Device Amendments, or to devices marketed in mierslate commeted provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will and provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the general on pro research practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval) it may be subject If your device is classifica (so above nate viass affecting your device can be found in the Code of Federal Regulations, To Such additional controls. Existing major regulated determination assumes compliance with the Current Good Manufacturing ITIE ZT, Paris 800 0 693. A Subsianty of Trailent Georgianion (QS) for Medical Devices: General regulation (21 CFR Partic Practice requirements, as set four in the Quality Dread Nog Administration (FDA) will Verify such as anyances and 820) and that, timough periodic QS mspecions, the Programs, In addition, FDA may publish further announcements to comply will the Unit Togulation may road. In regencies to your premarket notification submission does not concerning your device in the rederal Register. I 1660 notes under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I his letter will and would to begally marketed predicated 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 II you desire specific advice tor your de radition of (301) 594-4639. 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" (21CFR 807.97). Other general information on your entified, "Misoraliung of telefice to premation "(Ereires of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours
Nancy C Brogdon
Nancy C. Brogdon
Brogdon Nancy C Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number:
Koi 1773
Device Name:
Dornier Lithotripter 140
Indications for Use:
The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract The Domic Laronplor Tron ( S. ) ( ) = ) = s, renal pelvic stones, and upper ureteral stones.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| or | |
| Over-the-Counter Use |
Qirrd a. Lygom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K011773
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)