(256 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a catheter and stent set, with no mention of AI or ML.
Yes
The device is used for nephrostomy drainage and dynamic tamponade to prevent hemorrhage, which are therapeutic interventions.
No
Explanation: The device is described as being used for nephrostomy drainage and tamponade to prevent hemorrhage, which are therapeutic and preventative functions, not diagnostic ones. It is a catheter and stent set, not designed to diagnose a condition.
No
The device description clearly outlines physical components such as a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube, and syringe, and the performance studies focus on physical characteristics and functionality of these components. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for nephrostomy drainage and dynamic tamponade to prevent hemorrhage during surgical procedures (nephrolithotomy and percutaneous stone removal). This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a catheter and stent set designed to be inserted into the body for drainage and pressure application. It does not involve the examination of specimens derived from the human body for diagnostic purposes.
- Performance Studies: The performance studies listed focus on the physical and functional characteristics of the device (biocompatibility, sterility, dimensions, strength, flow rate, etc.) and its ability to perform its intended mechanical function within the body. There are no studies related to analyzing biological samples or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is used in vivo (inside the body) for a therapeutic and procedural purpose.
N/A
Intended Use / Indications for Use
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
Product codes (comma separated list FDA assigned to the subject device)
LJE
Device Description
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube and syringe. The balloon catheter can be sold separately with the stylet and syringe. The radiopaque balloon catheter has an outer diameter of 14.0 French and a tip diameter of 17.0 French, with a working length of 25 centimeters. The clear polyethylene balloon measures 15 centimeters in length and has an inflated diameter of 12 millimeters. The flexible stylet is 8.5 French and is manufactured from polyurethane material. The flexible stylet, designed to be inserted through the proximal end of the balloon catheter, extends 2 millimeters from the balloon catheter tip when assembled. The stent is manufactured from radiopaque polyurethane with an outer diameter of 5.0 French and a length of 75 centimeters. The stent is designed with two adjustable and removable adapters located at the proximal end of the stent. The Y-connecting tube is made of non-radiopaque polyvinylchloride material with an outer diameter of 14.0 French, and a length of 30 centimeters. A 10 mL Luerlock syringe is also provided in the set and is used to inflate the balloon through the inflation check valve.
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is supplied sterile in a Tyvek peel open pouch and labeled with a three-year shelf life. The subject device has a maximum indwell time of 96 hours (4 days) for the stent and 48 hours (2 days) for the balloon catheter and is labeled as a single-use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 were performed to demonstrate that The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set met applicable design and performance requirements and support a determination of substantial equivalence:
-
- Biocompatibility
-
- Sterility
-
- Packaging: Distribution and Stability
-
- Shelf-life
-
- Balloon Catheter:
- a. Compatibility
- b. Dimensional Verification
- c. Balloon Inflation Volume
- d. Balloon Catheter Rated Burst Pressure
- e. Tensile Test
- f. Radiopacity
-
- Stent:
- a. Compatibility
- b. Dimensional Verification
- c. Tensile Test
- d. Flow Rate Test
- e. Kink and Lumen Patency
- f. Radiopacity
-
- Stylet:
- a. Compatibility
- b. Dimensional Verification
- c. Tensile Test
-
- Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set:
- a. Liquid Leakage and Gravity Flow
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
July 16, 2019
Cook Incorporated Ian Herrman Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K183051
Trade/Device Name: Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set Kaye Nephrostomy Tamponade Balloon Catheter Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LJE Dated: June 10, 2019 Received: June 11, 2019
Dear Ian Herrman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183051
Device Name
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
Kaye Nephrostomy Tamponade Balloon Catheter Set
Indications for Use (Describe)
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image is a logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, bold, sans-serif font. The word "MEDICAL" is written in white, smaller, sans-serif font and is located below the word "COOK".
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON, IN 47402-04 W.COOKMEDIC
510(k) Summary
K183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set 21 CFR §807.92 Date Prepared: July 16, 2019
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Primary Contact: | Ian Herrman |
| Secondary Contact: | Karthik Pillai, Ph.D. |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Phone Number: | (812) 335-3575 x104034 |
| Fax Number | (812) 332-0281 |
Device Information:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Trade/Device Name: | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set |
| Kaye Nephrostomy Tamponade Balloon Catheter Set | |
| Device Common Name: | Catheter, Nephrostomy |
| Regulation Number: | N/A |
| Regulation Name: | N/A |
| Classification Product Code: | LJE |
| Device Class: | Unclassified |
| Review Panel: | Gastroenterology/Urology |
Predicate Devices:
- Malecot-Nephrostomy Tamponade Catheter, Cook Incorporated, K915209
- Expel™ Nephroureteral Stent System with Twist-Loc Hub, Boston Scientific, K141344 .
Device Description:
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral stent, flexible stylet, Y-connecting tube and syringe. The
4
balloon catheter can be sold separately with the stylet and syringe. The radiopaque balloon catheter has an outer diameter of 14.0 French and a tip diameter of 17.0 French, with a working length of 25 centimeters. The clear polyethylene balloon measures 15 centimeters in length and has an inflated diameter of 12 millimeters. The flexible stylet is 8.5 French and is manufactured from polyurethane material. The flexible stylet, designed to be inserted through the proximal end of the balloon catheter, extends 2 millimeters from the balloon catheter tip when assembled. The stent is manufactured from radiopaque polyurethane with an outer diameter of 5.0 French and a length of 75 centimeters. The stent is designed with two adjustable and removable adapters located at the proximal end of the stent. The Y-connecting tube is made of non-radiopaque polyvinylchloride material with an outer diameter of 14.0 French, and a length of 30 centimeters. A 10 mL Luerlock syringe is also provided in the set and is used to inflate the balloon through the inflation check valve.
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is supplied sterile in a Tyvek peel open pouch and labeled with a three-year shelf life. The subject device has a maximum indwell time of 96 hours (4 days) for the stent and 48 hours (2 days) for the balloon catheter and is labeled as a single-use device.
Intended Use:
MEDICA
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, ureteral drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The set sold without the stent component has the following intended use:
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
Comparison to Predicates:
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set and the predicate devices, the Malecot-Nephrostomy Tamponade Catheter (K915209) and the Expel™ Nephroureteral Stent System with Twist-Loc Hub (K141344), are substantially equivalent in that these devices share similar indications for use, methods of operations and fundamental technological characteristics. The Malecot-Nephrostomy Tamponade Catheter (K915209) is the predicate specifically for the balloon catheter component of the subject device set. The Expel™ Nephroureteral Stent System with Twist-Loc Hub
5
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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
(K141344) is the predicate specifically for stent component of the subject device set. Comparisons between each predicate and the corresponding subject device component are presented in the following tables.
Balloon Catheter and Stylet:
| Device
Characteristics | Predicate Device
K915209 - Malecot-
Nephrostomy Tamponade
Catheter | Subject Device
K183051 - Kaye
Nephrostomy
Tamponade Balloon
Catheter | Comparison |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Malecot-Nephrostomy
Tamponade Catheter is used
for nephrostomy drainage
and low pressure dynamic
tamponade to prevent
hemorrhage following
percutaneous stone removal. | Used for nephrostomy
drainage, and dynamic
tamponade to prevent
hemorrhage in
nephrolithotomy and
percutaneous stone
removal procedures. | The subject and the predicate
device are both used for
nephrostomy drainage, and
dynamic tamponade to prevent
hemorrhage following percutaneous
stone removal. The slight difference
in wording does not raise new
questions of safety and
effectiveness (S&E) as the balloons
are labeled with the same max
volume and pressure. |
| Placement Method | Percutaneous | Identical | Identical |
| Maximum Indwell
Time | 5 days | 2 days (48 hours) | The subject device has a shorter
maximum indwell time than the
predicate. This shorter indwell time
does not raise any new questions of
S&E. |
| General Design | Balloon Catheter with stylet
and syringe accessories | Identical | Identical |
| Materials | Balloon: Polyethylene
Catheter Tubing:
Polyethylene, non-
radiopaque tubing | Balloon: Polyethylene
Catheter Tubing:
Ethylene-vinyl acetate
copolymer, radiopaque | Material differences in these
catheters do not raise new questions
of S&E as demonstrated by
biocompatibility and performance
testing. |
| Balloon Length | 15 cm | Identical | Identical |
| Balloon Diameter | 12 mm | Identical | Identical |
| Max inflation
pressure | 40 psi | Identical | Identical |
| Catheter Length | 25.7 cm | 25 cm | The slight difference in length does
not raise questions of S&E. |
| Catheter Tip | 16 Fr malecot tip | 17 Fr dual sideport tip | The difference in tip diameter and
drainage opening type does not
raise different questions of S&E |
| Catheter Shaft
Diameter | 16 Fr | 14 Fr | The subject device catheter shaft
has a smaller outer diameter than
the predicate device. Performance
testing indicates the difference in
outer diameter raises no new
questions of S&E. |
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Image /page/6/Picture/0 description: The image shows the contact information for Cook Incorporated. The address is 750 Daniels Way, P.O. Box 489, Bloomington, IN 47402-0489 U.S.A. The phone number is 812.339.2235, and the toll-free number is 800.457.4500. The website is www.cookmedical.com.
The total length of the predicate stent is 65 cm with a working length
subject device is 75cm with a
of 22-28 cm. The total length of the
Regarding technological characteristics, the subject and predicate balloon catheter (K141344) devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., tip drainage design, dimensions, materials, etc.) The differences identified do not raise different questions of safety and/or effectiveness as compared to the predicate device, as stated in the table.
| Device
Characteristics | Predicate Device
K141344 - ExpelTM
Nephroureteral Stent
System with Twist-Loc
Hub | Subject Device
K183051 - Kaye
Nephrostomy
Tamponade Balloon
Catheter Stent | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Expel Nephroureteral
Stents are delivered
percutaneously and are
intended to establish
internal drainage from the
ureteropelvic junction to
the bladder while
maintaining external
access to the stent, as well
as providing external
drainage. | Used for nephrostomy
drainage, ureteral
drainage, and dynamic
tamponade to prevent
hemorrhage in
nephrolithotomy and
percutaneous stone
removal procedures. | The subject device has a different
indication for use statement
compared to predicate K141344.
However, the stent included in the
subject device has the same
intended use as the predicate
K141344, which is internal drainage
to the bladder and external drainage
from the ureteropelvic junction
while maintaining external access to
the stent. |
| Maximum Indwell
Time | 30 days | 4 days (96 hours) | The subject device stent component
has a 4 day maximum indwell time
which is shorter than that of the
predicate. Because the subject
device maximum indwell time falls
within that of the predicate device
no new questions of S&E are raised. |
| General Design | Single lumen
nephroureteral stent with
distal and proximal
retention pigtails with
sideports | Single lumen straight
nephroureteral stent with
sideports. | The predicate and subject device are
similar in general design. The main
difference in design is that the
predicate device has pigtails in the
bladder and ureteropelvic junction
for retention. In the subject, device
retention is assured either through
connection to the balloon catheter
through the proximal adapter and/or
anchoring the device to the patient.
Thus, the difference in design does
not raise new questions of S&E. |
| Materials | Radiopaque Flexithane | Radiopaque Polyurethane | Material differences between the
predicate and subject devices do not
raise new questions of S&E as
demonstrated by biocompatibility
and performance testing. |
Total: 75
(adjustable)
Working length: 33 cm
Stent:
Stent Length
Total: 65
Working length: 22-28 cm
Image /page/6/Picture/4 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font on a red background.
7
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON. IN 47402-0489 U.S.A. 2235 TOLL EREE: 800-457.4500 VWW.COOKMEDICAL.COM
Image /page/7/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom left corner.
| Device
Characteristics | Predicate Device
K141344 - Expel™
Nephroureteral Stent
System with Twist-Loc
Hub | Subject Device
K183051 - Kaye
Nephrostomy
Tamponade Balloon
Catheter Stent | Comparison |
|---------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | working length adjustable up to 33
cm. The total length and working
length of the subject device stent
encompasses the predicate stent and
does not generate any new questions
of S&E. |
| Stent Diameter | 8.3 and 10.3 Fr | 5 Fr | The subject device stent has a
smaller outer diameter compared to
the predicate device stent. The
smaller stent outer diameter ensures
that the predicate can be used in the
same patient anatomy as the
predicate. Performance testing has
demonstrated that this difference
does not generate any new questions
of S&E. |
As shown above, the indications for use statement of the subject device set including the stent component is not identical to the predicate device; however, the differences do not represent a new intended use as both the predicate device stent and subject device stent have the same intended use.
Regarding the technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., dimensions, materials, indwell time, etc.) The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Technological Characteristics:
The following tests were performed to demonstrate that The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set met applicable design and performance requirements and support a determination of substantial equivalence:
-
- Biocompatibility
-
- Sterility
-
- Packaging: Distribution and Stability
-
- Shelf-life
-
- Balloon Catheter:
- a. Compatibility
8
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 9.2235 TOLLEREE: 800-457.4500 WWW.COOKMEDICAL.COM
Image /page/8/Picture/1 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font.
- b. Dimensional Verification
- Balloon Inflation Volume C.
- d. Balloon Catheter Rated Burst Pressure
- e. Tensile Test
- Radiopacity f.
-
- Stent:
- Compatibility a.
- b. Dimensional Verification
- c. Tensile Test
- d. Flow Rate Test
- Kink and Lumen Patency e.
- Radiopacity f.
-
- Stylet:
- a. Compatibility
- b. Dimensional Verification
- c. Tensile Test
-
- Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set:
- a. Liquid Leakage and Gravity Flow
Conclusion:
The results of these tests provide reasonable assurance that the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set will perform as intended. The subject device does not raise different questions of safety and/or effectiveness as compared to the predicate devices. In conclusion, the results of these tests support a determination of substantial equivalence to the predicate devices.