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.

AI/ML Overview

The Aspire Introducer Needle, a single-use, sterile, non-pyrogenic, disposable product, underwent testing to ensure its reliable design and performance. The device is intended for guidewire introduction during percutaneous gastrointestinal procedures.

Here's a breakdown of the acceptance criteria and the study information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Needle to Hub bond strength	Test results met predetermined criteria.
Sheath to Handle bond strength	Test results met predetermined criteria.
Sterilization (EO)	Product is EO sterilized (implies successful sterilization).
Biocompatibility (ISO 10993-1:2009 series)	All applicable sections of ISO 10993-1:2009 series standards were successfully passed.
Verification and validation to product specifications and risk mitigation requirements	Successfully passed with all requirements met, demonstrating safety and effectiveness for intended use.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for each performance test (e.g., bond strength, biocompatibility). It generally states that "test articles" were used, implying a sample was taken for each test. The provenance of the data is from internal testing conducted by Aspire Bariatrics, Inc. and is likely prospective in nature as it is part of the premarket notification process for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a physical medical instrument, and its performance is evaluated through engineering tests, sterilization validation, and biocompatibility testing, not through expert-established ground truth on a dataset. The "ground truth" here is the adherence to established engineering specifications and regulatory standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical study data where multiple experts interpret cases. For device performance testing, the results are typically objectively measured against predetermined acceptance criteria.

5. If a multi-reader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The Aspire Introducer Needle is a physical medical device, not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical instrument and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluation of this device is based on established engineering specifications, recognized industry standards (e.g., ISO 10993-1), and regulatory requirements for medical devices. This includes predefined strength limits for bond tests, successful sterilization, and documented biocompatibility.

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set.

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 SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 theThe 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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

Confidential

{3}------------------------------------------------

510(k) Summary

Date Prepared:	March 15, 2018
Submitter:	Aspire Bariatrics, Inc.3200 Horizon Drive,Suite 100King of Prussia, Pa 19406Phone 610-590-1577Fax 610-279-1546
Company Contact:	Monica Ferrante, DPAVP Regulatory & QualityEmail monica.ferrante@aspirebariatrics.comPhone 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 NeedleK043258 Teleflex Medical, TFX Medical Safety Needle with Introducer
Device Description:	The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposableproduct used to provide initial percutaneous access. It is comprised of a stainlesssteel needle with a plastic sheath to be used in guidewire placement duringpercutaneous endoscopic procedures. The needle is used once the stomach isinsufflated and the site verified through trans-illumination and visualization offinger indentation through the endoscope. The introducer needle is similar indesign to other needles currently on the market for the same intended purpose.The dimensions of this device fall within the range of currently marketedintroducer needles with the same intended use, and the materials are similar inthat the needle is made from stainless steel and the other components areplastics. 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 ProductsInternational, Inc.	Teleflex Medical
Product Name	Introducer Needle	LumiLoc Safety IntroducerNeedle	Modified TFX Medical SafetyNeedle with Introducer
510(k)	TBD	K070449	K043258
Regulation	876.5980	876.5980	876.5980
Product Code	KNT	KNT	KNT
Indications forUse	The Aspire Introducer Needleis intended to be used forguidewire introduction duringpercutaneous gastrointestinalprocedures.	The LumiLoc Safety IntroducerNeedle is intended to be usedfor percutaneous proceduresutilizing a sheathed introducertrocar/needle for guidewireintroduction duringpercutaneous gastrointestinalprocedures.LumiLoc Safety IntroducerNeedle's engineered integralsafety guard is passivelyactivated by the clinician uponremoval of the trocar/needlefrom the introducer sheath.The LumiLoc Safety IntroducerNeedle helps to reduce the riskof accidental trocar/needlestickinjuries by locking a safety guardover the trocar/needle tip.	The Modified TFX MedicalSafety Needle withIntroducer is intended to beused for guidewireintroduction duringgastrointestinal proceduressuch as PEG (PercutaneousEndoscopic Gastrostomy),PEJ (PercutaneousEndoscopic Jejunostomy) orother endoscopicgastrointestinal proceduresrequiring placement of aguidewire.
Materials	Needle: 17 gauge passivated304 stainless steelFemale Luer Needle Hub:Polystyrene ClearCannula Sheath: High DensityPolyethylene with 10% BaSO4and 1% TiO White	Needle: stainless steelNeedle Hub: colored translucentCannula Sheath: not described	Needle: stainless steelLuer Hub: not describedCannula Sheath:polypropylene (previouslyHigh Density Polyethylene)
	Cannula Hub/T Handle: HighDensity Polyethylene WhiteProtective Sleeve: LowDensity Polyethylene Clear	Female Luer Cannula Hub:colored translucentSafety Needle: Seldinger shield	Cannula Hub: not describedSafety Needle: not described
Needle Length	10 cm needle plus bevellength of 0.5 cm	Not described	lengths between2.50" - 4.0"(6.35 - 10.16 cm)
Needle BevelIndicator	Yes, arrow on Trocar NeedleHub	Yes, bevel up indicator on TrocarNeedle Hub	Not described
Needle Gauge	17 Gauge(.058" OD x .048" ID) stainlesssteel needle with female luerlock hub	Not described	14 - 18 Gauge
Cannula SheathFrench size	4 F(.067±.002" ID)10 cm long cannula sheathwith over molded "T" handle	Not described	2F - 6F sizes
Cannula Sheath	Non-peelable	Non-peelable	Non-peelable
Guidewire size	Guidewire < 0.059"(<1.49mm)	Not described	guidewires from 0.015" -0.052"(0.38 - 1.32mm)
Protectivesheath	11.8 cm clear protectivesheath (covers and protectscannula and needle prior touse)	Safety Needle Seldinger shield	Safety Needle with passivesharps protection
Sterile	Yes EO	Yes - not specified	Yes

{5}------------------------------------------------

Technological Characteristics:

The Aspire Introducer Needle was subjected to applicable testing to assure reliable design and performance under test parameters. The tests are listed below:

. 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. ●

{6}------------------------------------------------

Product Materials:

All components are made with materials known for safe and effective use in medical devices. Duration of contact is transient. The Introducer Needle and Sheath are only used during the procedure to provide access through the abdominal wall to the stomach. Once the needle creates the path, it is removed and the cannula sheath remains in place for the guidewire. Once the guidewire is passed through and captured by the endoscope the gastrostomy tube is attached and pulled through the mouth down through the esophagus into the stomach and out through the newly created tract. The sheath is removed with the guidewire.

Needle: 17 gauge passivated 304 stainless steel Cannula Sheath: High Density Polyethylene with 10% BaSO4 and 1% TiO White Cannula Hub: High Density Polyethylene White Locking Hub: Polystyrene Clear Protective Sleeve: Low Density Polyethylene clear

Biocompatibility Testing:

The Aspire Introducer Needle has been tested for Biocompatibility based on the applicable sections of the ISO 10993-1:2009 series standards.

Performance Testing:

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.

Substantial Equivalence:

The Aspire Introducer Needle is similar to the predicate devices referenced. Differences are minor and do not raise new questions of safety or effectiveness. Therefore, the Aspire Introducer Needle is believed to be substantially equivalent to legally marketed gastrostomy accessory devices with regards to intended use, safety and effectiveness.

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.