(101 days)
Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of a feeding tube, with no mention of AI or ML capabilities.
Yes
The device is a feeding tube designed to deliver nutrition and manage gastrointestinal issues, which are therapeutic interventions.
No
This device is a feeding tube for nutritional support and gastric decompression, not for diagnosing medical conditions.
No
The device description clearly outlines a physical feeding tube with hardware components such as a balloon, external bolster, ports, and tubing. The performance studies also focus on the physical properties and performance of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a feeding tube used to deliver nutrition directly into the digestive system and to decompress the stomach. It is a physical device inserted into the body for therapeutic and supportive purposes.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples or providing diagnostic information about a patient's health status.
Therefore, the Micro Transgastric-Jejunal Feeding Device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Micro Transgastric-Jejunal Feeding Device is in children and adults who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy.
The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
Product codes (comma separated list FDA assigned to the subject device)
KNT, PIF
Device Description
The AMT Micro Transgastric-Jejunal feeding device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a gastric stoma. The tube in held in place (within the stoma tract) by means of an inflatable balloon and a low-profile external bolster. The external bolster contains two ports; one labeled "JEJUNAL" (glow green) and one labeled "GASTRIC" (white). Incorporated within each port is a one-way valve which is opened by attaching the appropriate AMT Extension Set. AMT Extension Sets are color coded and connect to the feeding and drainage ports. The JEJUNAL (glow green) port is used for feeding into the small intestine. The GASTRIC (white) port is used to drain the stomach with the use of low intermittent suction or gravity drainage. A third port labeled "BAL" is used to inflate and deflate the balloon.
The Micro Transgastric-Jejunal Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach, distal duodenum or proximal jejunum
Indicated Patient Age Range
Adult, adolescent, child, and infant patients over 6kg
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)
- Biocompatibility Testing: Following a Biological Evaluation Plan, the Micro Transgastric-Jejunal Feeding Device has been tested for biocompatibility based on the applicable sections of ISO 10993-1: 2009, ISO 10993-3: 2014, ISO 10993-5: 2009, ISO 10993-6: 2016, ISO 10993-7: 2008, ISO 10993-10: 2010, ISO 10993-11:2006, ISO 10993-12:2012, and ISO 10993-17:2002. A Biological Risk Assessment determined that the device met the acceptance criteria for permanent contact (greater than 30 days) with mucosal membrane and breached/compromised surfaces.
- Performance Testing: Bench tests were carried out to demonstrate conformance to applicable recognized standards and to compare performance to the predicate.
- Tests per AMT Design Specifications: Balloon Assembly Bond Peel/Tear Strength, Balloon Burst, Fill Valve Blow Out, Fill Valve Pullout, Flow Rate, Leak Test, Tensile Test to remove jejunal interlock, Tensile Test to remove gastric interlock, Tensile Test to tear tubing at jejunal hole, Tensile Test to tear tubing at gastric hole, Minimum Overmold External Bolster Bond Strength, Stoma Pullout, Tubing Tensile Test, Gastric Strap Tensile Test, Jejunal Strap Tensile Test.
- Tests per ASTM F2528-06: Balloon Integrity in Simulated Gastric Fluid, Balloon volume maintenance, Balloon size and shaft size, Balloon concentricity, Balloon integrity.
- Tests per ISO 80369-20: Fluid leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding, Disconnection by unscrewing.
- Tests per ASTM F2052: Magnetically induced displacement force.
- Tests per ASTM F2119: MR image artifact.
- Tests per ASTM F2182: Radio frequency induced heating.
- Key Results: The Micro Transgastric-Jejunal Feeding Device meets all the acceptance criteria and performed comparable to or better than the primary predicate.
- Animal Study: Not performed.
- Clinical Study: Not performed. Clinical evidence gathered from independent organizations has been included in the submission.
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2019
Applied Medical Technology, Inc. Joy Tubero Regulatory Affairs Specialist 8006 Katherine Boulevard Brecksville, OH 44141
Re: K183508
Trade/Device Name: Micro Transgastric-Jejunal Feeding Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIF Dated: February 25, 2019 Received: February 27, 2019
Dear Joy Tubero:
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/tray. The general controls 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
Page 2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -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
Indications for Use
510(k) Number (if known)
Device Name Micro Transgastric-Jejunal Feeding Device
Indications for Use (Describe)
The Micro Transgastric-Jejunal Feeding Device is inchildren and adults who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy.
The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
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
510(k) Summary
Micro Transgastric-Jejunal Feeding Device
I. SUBMITTER:
Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 Phone: 440-717-4000 Fax: 440-717-4200
Contact Person: Joy Tubero - Regulatory Affairs Specialist Email: joy.tubero@appliedmedical.net Date Prepared: December 14, 2018
II. DEVICE INFORMATION:
Trade/Device Name: Micro Transgastric-Jejunal Feeding Device Common Name: Gastrointestinal Tube Classification Name: Gastrointestinal Tube And Accessories Regulation Number: 21 CFR 876.5980 Product Code: KNT, PIF Regulatory Class: II Review Panel: Gastroenterology and Urology
III. PREDICATE INFORMATION:
Primary Predicate: AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit (K123716)
- The predicate device has not been subject to design-related recalls. .
INDICATIONS FOR USE: IV.
The Micro Transgastric-Jejunal Feeding Device is indicated for use in adult, adolescent, child, and infant patients over 6kg who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy.
The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
4
V. DEVICE DESCRIPTION:
The AMT Micro Transgastric-Jejunal feeding device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a gastric stoma. The tube in held in place (within the stoma tract) by means of an inflatable balloon and a low-profile external bolster. The external bolster contains two ports; one labeled "JEJUNAL" (glow green) and one labeled "GASTRIC" (white). Incorporated within each port is a one-way valve which is opened by attaching the appropriate AMT Extension Set. AMT Extension Sets are color coded and connect to the feeding and drainage ports. The JEJUNAL (glow green) port is used for feeding into the small intestine. The GASTRIC (white) port is used to drain the stomach with the use of low intermittent suction or gravity drainage. A third port labeled "BAL" is used to inflate and deflate the balloon.
The Micro Transgastric-Jejunal Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.
| TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE
PREDICATE DEVICES | ||
---|---|---|
Subject Device: Micro Transgastric-Jejunal Feeding | ||
Device | Predicate: AMT Low-Profile Transgastric- | |
Jejunal Feeding Tube Kit (K123716) | ||
Device Class and | ||
Product Code: | II, KNT, PIF | II, KNT |
Substantial Equivalence: | Same | |
Sterilization: | Sterile (Ethylene Oxide), single use only. | Sterile (Ethylene Oxide), single use only. |
Substantial Equivalence: | Same | |
Prescription | Single use: Prescription Only | Single use: Prescription Only |
Substantial Equivalence: | Same | |
MRI Safety | ||
Information | Labeled MR Conditional | Labeled MR Conditional |
Substantial Equivalence: | Same | |
TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE | ||
PREDICATE DEVICES | ||
Subject Device: Micro Transgastric-Jejunal Feeding | ||
Device | Predicate: AMT Low-Profile Transgastric- | |
Jejunal Feeding Tube Kit (K123716) | ||
Indications for | ||
Use: | The Micro Transgastric-Jejunal Feeding Device is | |
indicated for use in adult, adolescent, child, and infant | ||
patients over 6kg who cannot absorb adequate nutrition | ||
through the stomach, who have intestinal motility | ||
problems, gastric outlet obstruction, severe | ||
gastroesophageal reflux, are at risk of aspiration, or in | ||
those who have had previous esophagectomy or | ||
gastrectomy. |
The use of this tube is also clinically indicated when
simultaneous gastric decompression and jejunal feeding
are needed. This includes patients in whom
malnutrition already exists, or may result, secondary to
concurrent conditions. | The AMT Transgastric-Jejunal feeding tube is
indicated for use in patients who cannot absorb
adequate nutrition through the stomach, who have
intestinal motility problems, gastric outlet
obstruction, severe gastroesophageal reflux, are at
risk of aspiration, or in those who have had
previous esophagectomy or gastrectomy.
The use of this tube is also clinically indicated
when simultaneous gastric decompression and
jejunal feeding are needed. This includes patients
in whom malnutrition already exists, or may result,
secondary to concurrent conditions. |
| | Substantial Equivalence: | Similar |
| Intended Use: | Provide simultaneous gastric decompression/drainage
and delivery of enteral nutrition into the distal
duodenum or proximal jejunum. | Provide simultaneous gastric
decompression/drainage and delivery of enteral
nutrition into the distal duodenum or proximal
jejunum. |
| | Substantial Equivalence: | Same |
| Sizes: | • Tube Diameter: larger proximal-gastric Fr size, smaller
distal-jejunal Fr size | • Tube Diameter: entire length of device is one Fr
size |
| | Substantial Equivalence: | Similar |
| Principles of
Operation | • Deliver enteral nutrition directly into the small
intestine by enteral feeding pump.
• Allow gastric decompression by gravity (connect
extension set to gastric port, leaving the plug open), or
connect to low intermittent suction. | • Deliver enteral nutrition directly into the small
intestine by enteral feeding pump.
• Allow gastric decompression by gravity (connect
extension set to gastric port, leaving the plug
open), or connect to low intermittent suction. |
| | Substantial Equivalence: | Same |
| TABLE 5.1- TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT DEVICE AND THE
PREDICATE DEVICES | | |
| | Subject Device: Micro Transgastric-Jejunal Feeding
Device | Predicate: AMT Low-Profile Transgastric-
Jejunal Feeding Tube Kit (K123716) |
| Major Design
Characteristics | Medical grade silicone and polyurethane
construction External low-profile bolster: Jejunal feeding port with interlock and
strap/plug Gastric decompression port with interlock and
strap/plug Balloon fill valve Anti-reflux duckbill valves to help prevent leakage Inflatable silicone internal retention balloon Gastric and jejunal exit ports Anti-kink enforced Jejunal tubing Tapered distal tip Radiopaque barium sulfate to aid in visualization MR Conditional Sold as part of a kit with accessories | Medical grade silicone construction External low-profile bolster: Jejunal feeding port with interlock and
strap/plug Gastric decompression port with interlock
and strap/plug Balloon fill valve Anti-reflux duckbill valves to help prevent
leakage Inflatable silicone internal retention balloon Gastric and Jejunal exit ports Anti-kink enforced Jejunal portion of tubing
(16Fr & 18Fr only) Tapered distal tip with suture Radiopaque barium sulfate to aid in
visualization MR Conditional Sold as part of a kit with accessories |
| | Substantial Equivalence: | Similar |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATES:
5
SECTION – 5
6
As indicated above, minor differences exist among the Micro Transgastric-Jejunal Feeding Device and the predicate devices. These differences include:
- . Tubing Material: The subject device tubing is composed of silicone and polyurethane while the predicate tubing is constructed of silicone tubing.
- Size: The subject device is offered with a distal/jejunal Fr size of tubing that is smaller than that of the proximal/gastric Fr size whereas the Fr size is consistent throughout the entire length of the predicate device.
These minor design differences between the Micro Transgastric-Jejunal Feeding Device (subject device), and the predicate (K123716) do not raise different questions of safety and/or effectiveness from the predicate or the reference device. The intended use and indications for use remain the same between the Micro Transgastric-Jejunal Feeding Device and the predicate device.
VII. PERFORMANCE DATA:
- A. Biocompatibility Testing: Following a Biological Evaluation Plan, the Micro Transgastric-Jejunal Feeding Device has been tested for biocompatibility based on the applicable sections of the following standards:
- ISO 10993-1: 2009 Biological Evaluation of Medical Devices ●
7
- Part 1: Evaluation and testing within a risk management process
- ISO 10993-3: 2014 Biological Evaluation of Medical Devices ● - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices . - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-6: 2016 Biological Evaluation of Medical Devices . - Part 6: Test for local effects after implantation.
- . ISO 10993-7: 2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization.
- . ISO 10993-11:2006 Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity
- ISO 10993-12:2012 Biological Evaluation of Medical Devices ● - Part 12: Sample preparation and reference materials
- ISO 10993-17:2002 Biological Evaluation of Medical Device ● - Part 17: Sample preparation and reference materials
In accordance with a Biological Evaluation Plan, a Biological Risk Assessment was completed on the patient contacting materials and it was determined that the Micro Transgastric-Jejunal Feeding Device met the acceptance criteria for permanent contact (greater than 30 days) with mucosal membrane and breached/compromised surfaces.
- B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device.
- C. Electromagnetic Compatibility & Electrical Safety: There are NO electronic components related in any way to this device.
D. Performance Testing:
AMT conducted various performance tests on the components contained within the Micro Transgastric-Jejunal Feeding Device. Testing found that all components and materials met or exceeded design specifications established by AMT.
Bench tests have been carried out to demonstrate conformance to applicable recognized standards, as well as to compare performance to the predicate. The tests carried out are outlined below.
- Testing per AMT Design Specifications:
- Balloon Assembly Bond Peel/Tear Strength O
- Balloon Burst O
- Fill Valve Blow Out O
- Fill Valve Pullout O
8
- Flow Rate O
- Leak Test O
- Tensile Test to remove jejunal interlock O
- Tensile Test to remove gastric interlock O
- Tensile Test to tear tubing at jejunal hole O
- O Tensile Test to tear tubing at gastric hole
- Minimum Overmold External Bolster Bond Strength O
- Stoma Pullout O
- Tubing Tensile Test O
- Gastric Strap Tensile Test O
- Jejunal Strap Tensile Test O
- Testing per ASTM F2528-06: ●
- Balloon Integrity in Simulated Gastric Fluid O
- Balloon volume maintenance O
- Balloon size and shaft size O
- Balloon concentricity O
- Balloon integrity O
- . Testing per ISO 80369-20:
- Fluid leakage O
- Stress cracking O
- o Resistance to separation from axial load
- Resistance to separation from unscrewing O
- O Resistance to overriding
- O Disconnection by unscrewing
- Testing per ASTM F2052:
- Magnetically induced displacement force O
- Testing per ASTM F2119: ●
- o MR image artifact
- Testing per ASTM F2182:
- Radio frequency induced heating O
The Micro Transgastric-Jejunal Feeding Device meets all the acceptance criteria and performed comparable to or better than the primary predicate.
- E. Animal Study: Animal testing was NOT performed.
- F. Clinical Study: Clinical testing was NOT performed. Clinical evidence gathered from independent organizations has been included in the submission.
VIII. Conclusion:
9
The Micro Transgastric-Jejunal Feeding Device can be found substantially equivalent to the predicate device cleared under K123716 in intended use, performance, and principles of operation. The minor design differences between the subject device and the legally marketed predicate do not raise different questions of safety and/or efficacy, and the information submitted in this application demonstrates that the subject device is at least as safe and effective as the current legally marketed device.