(78 days)
Used to assist doctors when performing a prostate biopsy. Used to guide a needle, biopsy or catheter into the prostate gland. Used as an accessory in conjunction with an ultrasound transducer (892.1570). Used to improve needle placement vs. guiding needle with the finger. Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.
A tube, a cannula that is an accessory that snaps or rests (depending on configuration) onto an ultrasound transducer (892.1570). 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.
This document describes the Premarket Notification (510(k)) for a Transrectal Needle Guide, an accessory for ultrasound transducers. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study to prove acceptance criteria through performance metrics.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical performance targets and reported device performance data in the way one might expect for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity, accuracy).
Instead, the "acceptance criteria" are implied by the Substantial Equivalence Comparison Chart (Appendix D), which compares the new device (PROTEK Medical Products Inc.) with a predicate device (Civco Medical K875128/A) across various characteristics to demonstrate that the new device is as safe and effective as the predicate.
Here's a re-interpretation of the Appendix D chart in the context of "acceptance criteria" through substantial equivalence:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Indications for use (Ultrasound transducer needle guide) | Same as predicate |
| Target Population (Doctor's) | Same as predicate |
| Designed by (OEM, Doctor, PROTEK/Civco) | Similar (OEM, Doctor, PROTEK) |
| Design (Sizes & Shapes Varies) | Similar (Sizes & Shapes Varies) |
| Materials (Stainless steel, Medical grade plastic) | Same as predicate |
| Performance (Target fixtures, Mil Std 105E) | Same as predicate (Refers to manufacturing and quality standards, not clinical performance) |
| Sterility (ETO) | Same as predicate |
| Biocompatibility (ISO-10993) | 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) | Same as predicate |
| Packaging (TYVEK "Chevron Peel Pouch") | Same as predicate |
| Human Factor (No Known Adverse Effects) | Same as predicate |
Key takeaway: This 510(k) relies on demonstrating that the new device is the same as or very similar to existing, legally marketed devices, rather than providing novel performance data against specific, quantitative acceptance criteria via a clinical study. The "study" here is primarily a comparison analysis against predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the traditional sense of a dataset used for clinical evaluation of a device's performance (e.g., images for an AI algorithm, patient outcomes). The "study" is a comparison against predicate devices.
- Sample Size for Test Set: Not applicable/not provided for clinical performance
- Data Provenance: Not applicable/not provided for clinical performance. The comparison is based on the specifications, design, materials, and intended use of existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the clinical performance sense (e.g., confirmed disease status) is not established or used in this submission. The "ground truth" for the comparison is the established characteristics and regulatory status of the predicate devices. The "experts" involved are the device manufacturers and potentially regulatory bodies who approved the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (MRMC) is typically performed for diagnostic devices (e.g., imaging software) to assess the impact of AI assistance on human reader performance. The device in question is a simple mechanical accessory (needle guide), not a diagnostic algorithm.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
No. The device is a physical accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the new device's characteristics are substantially equivalent to these predicates, it shares the same safety and effectiveness profile.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is described.
Summary of the "Study" and "Acceptance Criteria" for K971115:
For this 510(k) submission, the "study" is primarily a comparison analysis against well-established, legally marketed predicate devices. The "acceptance criteria" are met by demonstrating substantial equivalence in terms of:
- Intended Use: The device shares the same intended use as the predicate (guiding needles/catheters in conjunction with ultrasound for prostate biopsies).
- Technological Characteristics: The device is made of similar materials (stainless steel, medical grade plastic), manufactured using similar methods, and designed to meet similar fundamental quality and safety standards (e.g., sterilization, biocompatibility, mechanical safety as confirmed by "end product tests" which are not detailed but are assumed to be similar to the predicate's). The only stated deviation is in "size and shape," which is considered a minor modification that doesn't alter the fundamental safety or effectiveness.
- Performance: The document mentions "Performance: Target fixtures, Mil Std 105E." This refers to manufacturing quality control standards and the ability to accurately guide a needle to a target, presumably demonstrated through standard manufacturing and design verification activities, rather than a clinical outcome study. The reference to "Mil Std 105E" implies statistical sampling plans for inspection, typical for manufacturing acceptance.
The FDA's decision (Section 4) of "substantial equivalence" confirms that the device meets the regulatory acceptance criteria by demonstrating it is as safe and effective as devices already on the market, without requiring new clinical performance data.
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1681 8 1 NUT
Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide
RODUCTS INC. 211 E. MARKET SURTE 291 IOWA CITY LA 319-358-8080 FAX 319-330-8258 USA 52245-2166
February 20, 1997
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 USA
SUMMARY PREMARKET NOTIFICATION 510 (k) FOR TRANSRECTAL 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
January 21, 1997 DATE SUMMARY PREPARED:
Trade Name:
.
Transrectal Needle/Biopsy Guide for Ultrasound Transducers Common Name:
Needle Guide, Puncher guide, Biopsy guide, Needle Guide system Classification Name:
Diagnostic Ultrasound Transducer Accessory 892.1570 ITX class 11
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Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide
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 | Civco | Civco's 510(k) |
| 1-535-0001 Guide | 612-045 | K875128/A |
| 1-535-0002 Guide | 612-035 | K875128/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(892.1570)
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 prostate biopsy
-
- Used to guide a needle, biopsy or catheter into the prostate gland.
-
- Used as an accessory in conjunction with an ultrasound transducer (892.1570)
-
- Used to improve needle placement vs. guiding needle with the finger
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:
(SEE ATTACHED CHART - APPENDIX D)
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Appendix D in SUMMARY
Substantially Equivalence Comparison Chart Yith Ciyco Medical 510(k) #K875128/A
| Description | PROTEK Medical Products Inc. | Civco Medical |
|---|---|---|
| Indications for use | Ultrasound transducerneedle guide | 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 |
| Biocompatibility | ISO-10993 | ISO-10993 |
| 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 |
| ManufacturingMethod | 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 Transducer 892.1570
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Rick L. Pruter President/CEO PROTEK Medical Products, Inc. 221 E. Market, Suite 291 Iowa City, IA 52245-2166
Re: K971115
1-535-0001 Transrectal Needle Guide for GE Medical and 1-535-0002 Transrectal Needle guide for Acuson, Inc. Dated: February 20, 1997 Received: February 27, 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 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 Good Manufacturing Pracioc for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices 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 of substantial equivalence of your device to a legally marketed predication 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 yitto diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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.
Jillian
Lillian Xia, Ph.D.
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
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Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide
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510(k) Number K971115
Statement Indication For Use
- I, Rick L. Pruter, President/CEO of PROTEK Medical Products Inc., certify that the devices in this notification are used for:
Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.
Ric
Rick L. Pruter, President/CEO PROTEK Medical Products Inc.
参
6-11-97
Date
David A. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.