(59 days)
Not Found
No
The device description and intended use focus on mechanical dilation and sheath placement. There is no mention of AI/ML, image processing, or data analysis capabilities.
No
The device is used for dilation and access of the nephrostomy tract, which are procedural steps rather than direct treatments of a disease or condition.
No
The device is used for mechanical procedures like dilation and sheath placement, not for diagnosing conditions.
No
The device description explicitly lists physical components such as catheters, dilators, and sheaths, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as being used in vivo (within the body) for physical procedures like dilation and placement of sheaths in the nephrostomy tract. IVDs are used in vitro (outside the body) to examine specimens from the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details physical components like dilators and sheaths, which are instruments used directly on the patient's anatomy.
- Anatomical Site: The specified anatomical site is the "nephrostomy tract," which is a part of the human body.
- Performance Studies: The performance studies listed (Biocompatibility, Compatibility Verification, Functional Verification, Radiopacity Verification, Shelf Life) are typical for medical devices used in vivo, not for IVDs which would focus on analytical and clinical performance related to specimen analysis.
There is no mention of the device being used to analyze biological specimens or provide diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
Amplatz Renal Dilator Set is intended for nephrostomy tract dilation and the placement of a sheath.
Catheter for Use with Amplatz Renal Dilator Set is intended to be used over a pre-positioned wire guide for percutaneous dilation and access of nephrostomy tract.
Amplatz Dilator is intended for nephrostomy tract dilation to allow for the placement of a sheath.
Amplatz Renal Introducer is intended to be used for nephrostomy tract dilation and the placement of a sheath.
Amplatz Radiopaque TFE Sheath is intended to be used as a working channel to maintain a previously established nephrostomy tract.
Clear Amplatz Sheath with Radiopaque Stripe is intended to be used as a working channel to maintain a previously established nephrostomy tract.
Product codes (comma separated list FDA assigned to the subject device)
LJE
Device Description
The Amplatz Renal Dilator Set contains the following components: an 8.0 French Catheter for Use with Amplatz Renal Dilator Set, various fascial dilators, a 10.0 French introducer sheath, various Amplatz Dilators, and various Amplatz Renal Introducers (an assembly of Amplatz Dilator and Amplatz Sheath). The set is intended for nephrostomy tract dilation and the placement of a sheath, which acts as a working channel during percutaneous nephrostomy procedures. It is supplied sterile and intended for one-time use.
The set includes components that may be sold separately with dimensional and material variances compared to the specifications of the original set components. The set components that are available in single sellable unit are as follows:
- Amplatz Renal Dilator Set
- Catheter for Use with Amplatz Renal Dilator Set
- Amplatz Dilator
- Amplatz Renal Introducer
- Amplatz Radiopaque TFE Sheath;
- Clear Amplatz Sheath with Radiopaque Stripe
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nephrostomy tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The following tests have been conducted to demonstrate that the Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, and Amplatz Sheath (Amplatz Radiopaque TFE Sheath; Clear Amplatz Sheath with Radiopaque Stripe) met applicable design and performance requirements.
- Biocompatibility
- Compatibility Verification
- Functional Verification
- Radiopacity Verification
- Shelf Life of Three Years Accelerated Aging
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 19, 2017
Cook Incorporated Rebecca Odulio (Li-Chun Liu) Regulatory Affairs Specialist 750 Daniels Way. P.O. Box 489 Bloomington, Indiana 47402
Re: K172527
Trade/Device Name: Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
Regulation Number: None Regulation Name: Unclassified Regulatory Class: Class II Product Code: LJE Dated: August 18, 2017 Received: August 21, 2017
Dear Rebecca Odulio (Li-Chun Liu):
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
2
510(k) Number (if known)
Device Name Amplatz Renal Dilator Set
Indications for Use (Describe)
Amplatz Renal Dilator Set is intended for nephrostomy tract dilation and the placement of a sheath.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
3
510(k) Number (if known)
Device Name
Catheter for Use with Amplatz Renal Dilator Set
Indications for Use (Describe)
Catheter for Use with Amplatz Renal Dilator Set is intended to be used over a pre-positioned wire guide for percutaneous dilation and access of nephrostomy tract.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
4
510(k) Number (if known)
Device Name Amplatz Dilator
Indications for Use (Describe)
Amplatz Dilator is intended for nephrostomy tract dilation to allow for the placement of a sheath.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
Expiration Date: January 31, 2017
See PRA Statement below.
510(k) Number (if known) K172527
Device Name Amplatz Renal Introducer
Indications for Use (Describe)
Amplatz Renal Introducer is intended to be used for nephrostomy tract dilation and the placement of a sheath.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
6
510(k) Number (if known) K172527
Device Name Amplatz Radiopaque TFE Sheath
Indications for Use (Describe)
Amplatz Radiopaque TFE Sheath is intended to be used as a working channel to maintain a previously established nephrostomy tract.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
7
510(k) Number (if known)
Device Name
Clear Amplatz Sheath with Radiopaque Stripe
Indications for Use (Describe)
Clear Amplatz Sheath with Radiopaque Stripe is intended to be used as a working channel to maintain a previously established nephrostomy tract.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
Image /page/8/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, bold, white letters on a red background. Below the word "COOK" is the word "MEDICAL" in white letters on a smaller red background. The logo is simple and clean, with a focus on the company name.
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Section 2.0 510(k) Summary
Amplatz Renal Dilator Set Catheter for Use with Amplatz Renal Dilator Set Amplatz Dilator Amplatz Renal Introducer Amplatz Radiopaque TFE Sheath Clear Amplatz Sheath with Radiopaque Stripe Date Prepared: October 19, 2017
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Rebecca Odulio (Li-chun Liu) |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x104673 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Device Trade Name | Common Name | Product Code | Regulation Number /Regulation
Name/Regulation Class/
Classification Panel |
|----------------------------------------------------|--------------------------|--------------|---------------------------------------------------------------------------------|
| Amplatz Renal Dilator Set | | | |
| Catheter for Use with Amplatz
Renal Dilator Set | | | |
| Amplatz Dilator | | | |
| Amplatz Renal Introducer | Catheter,
Nephrostomy | LJE | None,
Unclassified,
Class II,
Gastroenterology/Urology |
| Amplatz Radiopaque TFE Sheath | | | |
| Clear Amplatz Sheath with
Radiopaque Stripe | | | |
Predicate Devices:
- K851144: 8/10 Dilator/Sheath Set; Amplatz Type Renal Dilator Sheath; Amplatz Type ● Renal Sheath; Clear Renal Sheath (Van-Tec, Inc.)
- K820865: Amplatz Type Graduated Renal Dilator; Fascial Dilators (Van-Tec, Inc.) ●
9
Image /page/9/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The red background is a rectangle with a diagonal cut on the bottom left corner.
Device Description:
The Amplatz Renal Dilator Set contains the following components: an 8.0 French Catheter for Use with Amplatz Renal Dilator Set, various fascial dilators, a 10.0 French introducer sheath, various Amplatz Dilators, and various Amplatz Renal Introducers (an assembly of Amplatz Dilator and Amplatz Sheath). The set is intended for nephrostomy tract dilation and the placement of a sheath, which acts as a working channel during percutaneous nephrostomy procedures. It is supplied sterile and intended for one-time use.
The set includes components that may be sold separately with dimensional and material variances compared to the specifications of the original set components. The set components that are available in single sellable unit are as follows:
- Amplatz Renal Dilator Set ●
- Catheter for Use with Amplatz Renal Dilator Set .
- . Amplatz Dilator
- Amplatz Renal Introducer ●
- Amplatz Radiopaque TFE Sheath; ●
- Clear Amplatz Sheath with Radiopaque Stripe
Indications for use:
The Amplatz Renal Dilator Set is intended for nephrostomy tract dilation and the placement of a sheath.
The Catheter for Use with Amplatz Renal Dilator Set is intended to be used over a pre-positioned wire guide for percutaneous dilation and access of nephrostomy tract.
The Amplatz Dilator is intended for nephrostomy tract dilation to allow for the placement of a sheath.
The Amplatz Renal Introducer is intended to be used for nephrostomy tract dilation and the placement of a sheath.
The Amplatz Radiopaque TFE Sheath is intended to be used as a working channel to maintain a previously established nephrostomy tract.
10
Image /page/10/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font in the upper portion of the logo. Below "COOK" is the word "MEDICAL" in white, smaller, sans-serif font.
COOK INCORPORATED COOKMEDICAL.COM
The Clear Amplatz Sheath with Radiopaque Stripe is intended to be used as a working channel to maintain a previously established nephrostomy tract.
Comparison to Predicates:
The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicates. The differences between the subject devices and the predicate devices include minor dimensional variations and materials. Characteristics of the subject devices that differ from the predicate devices are supported by testing. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices.
Technological Characteristics:
The following tests have been conducted to demonstrate that the Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, and Amplatz Sheath (Amplatz Radiopaque TFE Sheath; Clear Amplatz Sheath with Radiopaque Stripe) met applicable design and performance requirements.
- Biocompatibility
- Compatibility Verification ●
- Functional Verification ●
- . Radiopacity Verification
- Shelf Life of Three Years Accelerated Aging ●
Conclusion:
All predetermined acceptance criteria of the testing were met. Therefore, the results of these tests support a conclusion that the subject devices perform as intended and support a determination of substantial equivalence to the predicate devices.