Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a simple introducer needle, with no mention of AI or ML capabilities.

Therapeutic

No
The device is an introducer needle used for guidewire placement, which is an access tool rather than a device designed to directly treat a medical condition or restore function.

Diagnostic

No

The device description clearly states its purpose is for "guidewire introduction during percutaneous gastrointestinal procedures" and "to provide initial percutaneous access." It does not mention any function for diagnosing conditions, only for facilitating a medical procedure.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a stainless steel needle and plastic sheath, indicating it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Aspire Introducer Needle is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for "guidewire introduction during percutaneous gastrointestinal procedures." This describes a surgical or interventional procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
Device Description: The description details a needle and sheath used for direct access into the body, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD device.

IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Aspire Introducer Needle is a surgical/interventional tool used during a procedure on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Aspire Introducer Needle is intended to be used for guidewire introduction during percutaneous gastrointestinal procedures.

Product codes (comma separated list FDA assigned to the subject device)

KNT

Device Description

The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable product used to provide initial percutaneous access. It is comprised of a stainless steel needle with a plastic sheath to be used in guidewire placement during percutaneous endoscopic procedures. The needle is used once the stomach is insufflated and the site verified through trans-illumination and visualization of finger indentation through the endoscope. The introducer needle is similar in design to other needles currently on the market for the same intended purpose. The dimensions of this device fall within the range of currently marketed introducer needles with the same intended use, and the materials are similar in that the needle is made from stainless steel and the other components are plastics. The device also incorporates a female luer lock hub in the design, also provided in the predicate devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal

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 Aspire Introducer Needle was subjected to applicable testing to assure reliable design and performance under test parameters.

Needle to Hub bond strength – Test article must meet the specified strength requirements. Test results met predetermined criteria.
Sheath to Handle bond strength – Test article must meet the specified strength requirements. Test results met predetermined criteria.
Sterilization Product is EO sterilized.
Verification and validation of the Aspire Introducer Needle to the product specifications and risk mitigation requirements demonstrate that the device is safe and effective for its intended use. Engineering testing, biocompatibility and sterilization validation have all been performed and successfully passed with all requirements met. The performance data detailed in the 510(k) submission demonstrate substantial equivalence to the predicated devices.

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.

K070449, K043258

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size, with "ADMINISTRATION" written below in a smaller font size.

July 11, 2018

Aspire Bariatrics, Inc. Monica Ferrante VP Regulatory & Ouality 3200 Horizon Drive, Suite 100 King of Prussia, PA 19406

Re: K180725

Trade/Device Name: Aspire Introducer Needle Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: June 15, 2018 Received: June 20, 2018

Dear Monica Ferrante:

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 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.

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 medical devices and radiation-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,

Glenn B. Bell -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

| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |

-------------------------------------------------------------------------	---------------------------------------------------------------------------------------------

Indications for Use

510(k) Number (if known)	K180725
Device Name	Aspire Introducer Needle

Indications for Use (Describe)
The Aspire Introducer Needle is intended to be used for guidewire introduction during percutaneous gastrointestinal 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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Confidential

3

510(k) Summary

Date Prepared:	March 15, 2018
Submitter:	Aspire Bariatrics, Inc.
3200 Horizon Drive,
Suite 100
King of Prussia, Pa 19406
Phone 610-590-1577
Fax 610-279-1546
Company Contact:	Monica Ferrante, DPA
VP Regulatory & Quality
Email monica.ferrante@aspirebariatrics.com
Phone 484-200-1031
Device Trade Name:	Aspire Introducer Needle
Classification Name:	Tubes, Gastrointestinal (and accessories)
Classification Regulation:	21 CFR 876.5980
Product Code:	KNT
Regulatory Class:	II
Review Panel:	Gastroenterology and Urology
Common Name:	Introducer Needle
Predicate Devices:	K070449 Specialized Health Products, LumiLoc Safety Introducer Needle
K043258 Teleflex Medical, TFX Medical Safety Needle with Introducer
Device Description:	The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable
product used to provide initial percutaneous access. It is comprised of a stainless
steel needle with a plastic sheath to be used in guidewire placement during
percutaneous endoscopic procedures. The needle is used once the stomach is
insufflated and the site verified through trans-illumination and visualization of
finger indentation through the endoscope. The introducer needle is similar in
design to other needles currently on the market for the same intended purpose.
The dimensions of this device fall within the range of currently marketed
introducer needles with the same intended use, and the materials are similar in
that the needle is made from stainless steel and the other components are
plastics. The device also incorporates a female luer lock hub in the design, also

provided in the predicate devices.

4

The Aspire Introducer Needle is intended to be used for guidewire introduction Intended Usage: during percutaneous gastrointestinal procedures.

Comparison to Predicates:

| Submitter | Aspire Bariatrics, Inc. | Specialized Health Products
International, Inc. | Teleflex Medical |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Introducer Needle | LumiLoc Safety Introducer
Needle | Modified TFX Medical Safety
Needle with Introducer |
| 510(k) | TBD | K070449 | K043258 |
| Regulation | 876.5980 | 876.5980 | 876.5980 |
| Product Code | KNT | KNT | KNT |
| Indications for
Use | The Aspire Introducer Needle
is intended to be used for
guidewire introduction during
percutaneous gastrointestinal
procedures. | The LumiLoc Safety Introducer
Needle is intended to be used
for percutaneous procedures
utilizing a sheathed introducer
trocar/needle for guidewire
introduction during
percutaneous gastrointestinal
procedures.

LumiLoc Safety Introducer
Needle's engineered integral
safety guard is passively
activated by the clinician upon
removal of the trocar/needle
from the introducer sheath.

The LumiLoc Safety Introducer
Needle helps to reduce the risk
of accidental trocar/needlestick
injuries by locking a safety guard
over the trocar/needle tip. | The Modified TFX Medical
Safety Needle with
Introducer is intended to be
used for guidewire
introduction during
gastrointestinal procedures
such as PEG (Percutaneous
Endoscopic Gastrostomy),
PEJ (Percutaneous
Endoscopic Jejunostomy) or
other endoscopic
gastrointestinal procedures
requiring placement of a
guidewire. |
| Materials | Needle: 17 gauge passivated
304 stainless steel

Female Luer Needle Hub:
Polystyrene Clear

Cannula Sheath: High Density
Polyethylene with 10% BaSO4
and 1% TiO White | Needle: stainless steel

Needle Hub: colored translucent

Cannula Sheath: not described | Needle: stainless steel

Luer Hub: not described