(62 days)
Accessory-Needle Guides used for Vaginal Ultrasound Transducers for performing Vaginal Biopsies.
A tube, a cannula that is an accessory that snaps or rests(depending on configuration) onto an ultrasound transducer(884.2960)
A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system
A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers
The provided document is a 510(k) premarket notification for a Transvaginal Needle Guide. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data to prove novel safety and effectiveness. Therefore, the information typically found in a study proving acceptance criteria for a new medical device (like detailed performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies) is largely absent.
Instead, the document highlights that the new device (PROTEK Medical Products Inc.'s Transvaginal Needle Guide) is "substantially equivalent" to existing, legally marketed devices, primarily those by Civco Medical Instruments and Amedic. The equivalence is based on similar design, materials, manufacturing, intended use, and performance claims rather than a new clinical study.
Here's an analysis based on the information provided, explicitly noting what is not available as it's not typically required for a 510(k) of this nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Indications for use | "Ultrasound transducer needle guide (accessory)" |
| Target Population | "Doctors" |
| Design | "Sizes & Shapes Varies" (similar to predicate) |
| Materials | "Stainless steel, Medical grade plastic" |
| Performance | "Target fixtures, Mil Std 105E" (same as predicate) |
| Sterility | "ETO" (same as predicate) |
| Mechanical Safety | "end product tests" (same as predicate) |
| Chemical Safety | "No Hazardous Components, 29CFR 1910.1200" (same as predicate) |
| Anatomical Sites | "Where Ultrasound is Used" (same as predicate) |
| Disposition | "Disposable" (same as predicate) |
| Where Used | "Hospitals & Clinics" (same as predicate) |
| Standards Met | "Mil Std 105E on voluntary standards" (same as predicate) |
| Electrical Safety | "No Electrical Components" (same as predicate) |
| Manufacturing Method | "Injection molded clips and purchased surgical tube" (similar to predicate) |
| Packaging | "TYVEK 'Chevron Peel Pouch'" (similar to predicate) |
| Human Factor | "No Known Adverse Effects" (same as predicate) |
Explanation: The "acceptance criteria" for this 510(k) submission are implicitly defined by the characteristics and performance of the predicate devices. The "reported device performance" is essentially a claim of identical or highly similar characteristics and performance to these predicates. The document explicitly states: "These new devices are the same as devices being legally marketed by several companies." and "The new devices design, manufacturing, labeling and its intended uses are the same as many existing devices currently being marketed by Civco Medical Instruments, and Amedic among others."
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: The document does not describe a new clinical "test set" or study in the traditional sense with specific sample sizes. The claim of equivalence is based on the known performance and design of predicate devices already on the market. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a new study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: No new clinical test set is described, so there's no mention of experts establishing a ground truth for such a set. The "ground truth" for the device's functionality is assumed to be established by the long-standing use and acceptance of the predicate devices in clinical practice. The document does mention "Doctor" as a designer for both the new and predicate devices, implying clinical input in the initial design of similar devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: No new clinical test set is described, so 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: This device is a mechanical needle guide accessory for ultrasound transducers, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related comparative effectiveness data is irrelevant and not provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: This is a mechanical device, not an algorithm. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Ground Truth: The ground truth is implicitly based on the established safety and efficacy of the predicate devices in clinical use, which would have been validated through their own historical regulatory pathways, including clinical experience and potentially outcomes data over time (though not explicitly detailed in this document for those devices). For the PROTEK device, the ground truth is that it performs "the same" as these predicate devices.
8. The sample size for the training set:
- Not Applicable / Not Provided: As this is a mechanical device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: See point 8.
In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence to predicate devices already on the market. It does not present novel study data to prove the device meets acceptance criteria because the criteria are based on the established performance of its legally marketed counterparts. The safety and effectiveness are argued to be the same due to similar design, materials, intended use, and manufacturing processes.
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Document # 9-926-0006 Rev. 1 FDA 510(k) Notification-Vaginal Ultrasound Needle Guide
JUL 10 1997
L PRODUCTS INC.
May 1, 1997
Document Mail Center Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA
SUMMARY PREMARKET NOTIFICATION 510 (k) FOR TRANSVAGINAL NEEDLE GUIDE an ULTRASOUND TRANSDUCER ACCESSORY
SUBMITTER: COMPANY: ADDRESS: CITY: STATE: COUNTRY: CONTACT: PHONE: FAX:
Rick L. Pruter PROTEK Medical Products Inc. 221 East Market Street Iowa City lowa USA Rick L. Pruter (319)358-8080 (319)339-8258
May 1. 1997 DATE SUMMARY PREPARED:
Trade Name:
Trans vaginal Needle/Biopsy Guide for Ultrasound Transducers Common Name:
Needle Guide, Puncher guide, Biopsy guide, Needle Guide system, Endocavity Needle Guide
Classification Name:
Not Known
6-1
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6-2
SUMMARY
COMMERCIALLY PRODUCED PRODUCTS OF EQUIVALENCE:
Substantial Equivalence Comparison:
These new devices are the same as devices being legally marketed by several companies.
The new devices design, manufacturing, labeling and its intended uses are the same as many existing devices currently being marketed by Civco Medical Instruments, and Amedic among others. The only deviation is in the size and shape. Owner of this new company is co-inventor of these products and was an officer at Civco, one of the companies we are claiming substantial equivalence.
The following is a cross reference of products that will be identical:
New Device
PROTEK Medical Inc 1-535-0003 Guide 1-535-0004 Guide
Civco 677-027 6000-0022-1 A Civco's 510(k) K875240/A K875240/A
*Other part numbers vary only in size and shape
Commercially Produced Products of Equivalence:
There are several products of equivalence legally marketed by companies including the following:
Civco Medical from Iowa, USA Amedic of Sweden, . GE Medical Wis. USA.
Other known companies that legally market this device:
ATL Bothell Washington Siemens Medical Systems Isaque Washington Diasonics San Jose Calif. Toshiba Tustin, California among others
Comparison: (see Comparison Chart Appendix D-1)
These devices are similar to several predicate devices legally marketed in respect to the materials, packaging, distribution and intended use. There are several hundred different configurations that Civco and Amedic are currently legally marketing for the (OEM)original equipment manufacturers. The original equipment manufacturers also legally markets these devices. This notification compares our product with Civco,s and Amedic and GE Medical.
These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures and the same people that tested and processed Civco's legally marketed devices.
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SUMMARY
DEVICE DESCRIPTION:
Narrative Description:
A tube, a cannula that is an accessory that snaps or rests(depending on configuration) onto an ultrasound transducer(884.2960)
A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system
Device Physical Specifications:
A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers
Intended use:
-
Used to assist doctors when performing a vaginal biopsy
-
Used to guide a needle, biopsy or catheter into the vaginal gland.
-
Used as an accessory in conjunction with an ultrasound transducer (884.2960)
-
Used as an accessory in conjunction with Ultrasound systems (892.1560)
-
Used to improve needle placement vs. guiding needle with the finger
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:
(SEE ATTACHED CHART - APPENDIX D)
PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone (319)358-8080 Fax (319)339-8258
... .. ...
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Document # 9-926-0006 Rev. 1 FDA 510(k) Notification-Vaginal Ultrasound Needle Guide
6-4
Appendix D in SUMMARY
Substantially Equivalence Comparison Chart With Civco Medical 510(k) #K875240/A
| Description | PROTEK Medical Products Inc. | Civco Medical |
|---|---|---|
| Indications for use | Ultrasound transducerneedle guide (accessory) | Ultrasound transducerneedle guide |
| Target Population | Doctor's | Doctor's |
| Designed by | OEM. Doctor. PROTEK | OEM. Doctor. Civco |
| Design | Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials | Stainless steelMedical grade plastic | Stainless steelMedical grade plastic |
| Performance | Target fixturesMil Std 105E | Target FixturesMil Std 105E |
| Sterility | ETO | ETO |
| Mechanical Safety | end product tests | end products tests |
| Chemical Safety | No Hazardous Components29CFR 1910.1200 | No Hazardous Components29CFR 1910.1200 |
| Anatomical Sites | Where Ultrasound is Used | Where Ultrasound is Used |
| Disposition | Disposable | Disposable |
| Where Used | Hospitals & Clinics | Hospitals & Clinics |
| Standards Met | Mil Std 105E on voluntarystandards | Mil Std 105E on voluntarystandards |
| Electrical Safety | No Electrical Components | No Electrical Components |
| Manufacturing Method | Injection molded clips andpurchased surgical tube | Injection molded clips andpurchased surgical tube |
| Packaging | TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor | No Known Adverse Effects | No Known Adverse Effects |
*OEM definition: Original Equipment manufacturer of Ultrasound Systems(892.1560) including Ultrasound Transducer manufacturers (884.2960)
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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is centered on the page. To the left of the text is a graphic of three diagonal lines.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 1997
Re: K971722
Rick L. Pruter President / CEO PROTEK Medical Products, Inc. 221 E. Market, Suite 291 Iowa City, Iowa 52245-2166
1-535-0003 Transvaginal Needle Guide for Shimadzu and 1-535-0004 Transvaginal Needle Guide for Acoustic Imaging, Inc. Dated: May 5, 1997 Received: May 9, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Pruter:
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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, 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 Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (CFR Part 820) and that, through periodic OS 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.
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sameling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a c!assification for your device and thus permits your device to proceed to market.
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Page 2 - Mr. Rick Pruter
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) 594-4591. 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html."
If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Document # 9-926-0006 Rev. 1 FDA 510(k) Notification-Vaginal Ultrasound Needle Guide
| 510(k) Number (if known) | K971722 |
|---|---|
| -------------------------- | --------- |
Device Name: Trans Vaginal Needle Guide ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indication for Use:
Accessory-Needle Guides used for Vaginal Ultrasound Transducers for performing Vaginal Biopsies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE TO ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT,
Radiological Devices
510(k) Number K971722
Prescription Use
(Per 21 CFR 801.109)
OR
Over The Counter Use
(Optional Format 1-2-96)
ત્ત્વન્ત્વ
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.