(225 days)
No
The device description and performance studies focus on physical components and mechanical/biocompatibility testing, with no mention of AI or ML.
No
The device is intended to assist with the placement of feeding tubes, it is not the feeding tube itself, nor does it directly treat a disease or condition. It is an accessory tool for a medical procedure.
No
Explanation: The device description and intended use clearly state that this device is designed to assist with the initial placement of feeding tubes during a gastrostomy. It is a surgical tool, not a device used for diagnosis. The performance studies listed are for mechanical and biocompatibility testing, not diagnostic accuracy.
No
The device description explicitly lists multiple physical components made of materials like stainless steel and PTFE, and the performance studies focus on the physical properties and biocompatibility of these components.
Based on the provided information, the Entuit Start Initial Placement Gastrostomy Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist a physician with the initial placement of feeding tubes during a gastrostomy procedure in adult patients. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device components (wire guide, dilators, introducers, needle, scalpel, syringe, gauze) are all instruments used for a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not perform any such analysis of specimens.
Therefore, the Entuit Start Initial Placement Gastrostomy Set is a surgical/interventional device, not an IVD.
N/A
Intended Use / Indications for Use
The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.
Product codes
KGC
Device Description
The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy duty stainless steel polytetrafluoroethylene (PTFE) coated Amplatz extra stiff wire guide, dilators, and one or more Peel-Away® Introducers. Depending upon set specifications, two or three dilators may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.
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
adult patients only
Intended User / Care Setting
physician
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 subject Entuit™ Start Initial Placement Gastrostomy Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:
- . Compatibility - (Peel away sheath and Gastrostomy Catheter, Dilator and Wire Guide, Needle and Wire Guide)
- Wire Guide Tensile ●
- Wire Guide Corrosion
- Wire Guide Flex ●
- Wire Guide Fracture .
- Dilator Shaft Tensile ●
- . Dilator Hub-to-Shaft Tensile
- . Peel-Away Introducer Shaft Tensile
- Peel-Away Introducer Knob-to-Shaft Tensile
- . Peel Force Testing
- Radiopacity Testing
- Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for ● cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and acute systemic toxicity were performed to ensure the biocompatibility of the subject device set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked one in front of the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2017
Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
K170323 Re:
Trade/Device Name: Entuit Start Initial Placement Gastrostomy Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KGC Dated: August 8, 2017 Received: August 9, 2017
Dear Erum B. Nasir:
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.
1
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 (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); 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
Indications for Use
510(k) Number (if known) K170323
Device Name
Entuit Start Initial Placement Gastrostomy Set
Indications for Use (Describe)
The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.
| 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)
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3
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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
1.0 510(k) SUMMARY
Entuit™ Start Initial Placement Gastrostomy Set As required by 21 CFR §807.92 Date Prepared: September 14, 2017
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact: | Erum B. Nasir |
| Email: | RegSubmissions@CookMedical.com |
| Contact Phone Number: | (812) 335-3575 x102607 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Entuit™ Start Initial Placement Gastrostomy Set |
|---|---|
| Common Name: | Gastrointestinal tube and accessories |
| Classification Name: | Tube, Gastro-Enterostomy |
| Regulation: | 21 CFR §876.5980 |
| Product Code: | KGC |
| Device Class: | II |
| Classification Panel: | Gastroenterology/Urology |
Predicate Device:
The Entuit™ Start Initial Placement Gastrostomy Set is substantially equivalent to the Kimberly-Clark Introducer Kits (K080253), cleared by FDA on February 26, 2008.
Device Description:
The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy duty stainless steel polytetrafluoroethylene (PTFE) coated Amplatz extra stiff wire guide, dilators, and one or more Peel-Away® Introducers. Depending upon set specifications, two or three dilators
4
2
Cook Incorporated - Traditional 510(k) Entuit Start Initial Placement Gastrostomy Set 14 SEP 2017
may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.
Intended Use:
The Entuit™ Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.
Comparison to Predicate Device:
The Entuit™ Start Initial Placement Gastrostomy Set and the predicate device, the Kimberly-Clark Introducer Kits (K080253), are substantially equivalent in that these devices are similar in intended use and principles of operation. The differences between the subject device and the predicate device, including the materials, dimensions, and components within the sets, do not raise any new issues of safety and effectiveness. The substantial equivalence comparison of the subject device to the predicate device is provided in the table below.
| | | Kimberly-Clark Introducer Kits
(K080253) | Entuit™ Start Initial Placement
Gastrostomy Set
(Subject of this submission) |
|----------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Regulation Number | 21 CFR §876.5980 | Identical |
| Product Code | | KGC | Identical |
| Classification | | Class II | Identical |
| | Intended Use | The Kimberly-Clark Introducer Kits are
intended to facilitate primary placement
of Kimberly-Clark, Kimberly-Clark
MIC and Kimberly-Clark MIC-KEY
brand of gastrostomy feeding tubes. | The Entuit Start Initial Placement
Gastrostomy Set is intended to assist
the physician with the initial placement
of feeding tubes while performing a
gastrostomy in adult patients only. |
| | Material | Unknown | Stainless Steel |
| Wire
Guide | Diameter
(inch) | 0.035 | 0.038 |
| | Length
(cm) | Unknown | 100 |
| Dilator | Diameter
(Fr) | Not included | 12, 14, 16, 18, 20, 22, 24 |
| | Length (cm) | Not included | 20 |
| | Shaft
Material | Not included | Polyethylene (12 Fr Dilator),
Polyvinyl chloride (14 - 24 Fr dilators) |
| | Hydrophilic
Coating | Unknown | Yes |
5
| | | Kimberly-Clark Introducer Kits
(K080253) | Entuit™ Start Initial Placement
Gastrostomy Set
(Subject of this submission) |
|-------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Peel-Away
Introducer
(Sheath
and
Dilator) | Diameter
(Fr) | 16, 18, 20, 22, 24* | 16, 18, 20, 22, 26 |
| | Sheath
Material | NA | Polytetrafluoroethylene (PTFE) |
| | Sheath
Length (cm) | N/A | 15.5 (for 16 & 18 Fr)
13 (for 20 - 24 Fr) |
| | Dilator Shaft
Material | Unknown | Polyvinyl chloride |
| | Dilator
Length (cm) | N/A | 20 |
| | Compatible Gastrostomy
tube size (Fr) | 12, 14, 16, 18, 20 | 12, 14, 16, 18, 20, 22, 24 |
| Gastrointestinal Anchor
Set | | Gastrointestinal Anchor Set with Saf-T-
Pexy* T-Fasteners | Not included with set - FDA cleared
(K131201and K152524), sold
separately |
| Accessory components | | 18 g Safety introducer needle
Safety Scalpel No.11 Blade
12 ml syringe
Hemostat
Stoma Measuring Device | 18 g entry access needle
Safety Scalpel No.11 Blade
6cc syringe
Gauze** |
| | Packaging | Unknown | Tray: Polyethylene terephthalate
Pouch: Polyethylene, Tyvek
Spiral Holder: Polyethylene |
| | Sterilization | Ethylene oxide | Identical |
| | Sterility Assurance Level
(SAL) | Unknown | 10-6 |
*Device includes serial dilators with varying size increments.
**Stoma measuring device is cleared under K130674 and is sold separately.
Technological Characteristics:
The subject Entuit™ Start Initial Placement Gastrostomy Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:
- . Compatibility - (Peel away sheath and Gastrostomy Catheter, Dilator and Wire Guide, Needle and Wire Guide)
- Wire Guide Tensile ●
- Wire Guide Corrosion
- Wire Guide Flex ●
- Wire Guide Fracture .
- Dilator Shaft Tensile ●
- . Dilator Hub-to-Shaft Tensile
6
Cook Incorporated - Traditional 510(k) Entuit Start Initial Placement Gastrostomy Set 14 SEP 2017
- . Peel-Away Introducer Shaft Tensile
- Peel-Away Introducer Knob-to-Shaft Tensile
- . Peel Force Testing
- Radiopacity Testing
- Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for ● cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and acute systemic toxicity were performed to ensure the biocompatibility of the subject device set.
Conclusion:
The results of these tests show that the Entuit™ Start Initial Placement Gastrostomy Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and support a determination of substantial equivalence.