Aspire Introducer Needle

K180725 · Aspire Bariatrics, Inc. · KNT · Jul 11, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180725
• Device Name: Aspire Introducer Needle
• Applicant: Aspire Bariatrics, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

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

Device Story

Single-use, sterile, disposable introducer needle for percutaneous gastrointestinal access. Comprised of 17-gauge 304 stainless steel needle, plastic cannula sheath, and female luer lock hub. Used during percutaneous endoscopic procedures after stomach insufflation and site verification via trans-illumination and endoscopic visualization. Clinician inserts needle through abdominal wall to stomach; cannula sheath remains in place for guidewire passage. Once guidewire is captured by endoscope, gastrostomy tube is attached and pulled through esophagus into stomach. Device facilitates initial access; sheath removed with guidewire. Benefits include reliable percutaneous access for gastrostomy tube placement.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including needle-to-hub and sheath-to-handle bond strength testing, and biocompatibility testing per ISO 10993-1:2009. All testing met predetermined acceptance criteria.

Technological Characteristics

17-gauge passivated 304 stainless steel needle; High Density Polyethylene (HDPE) cannula sheath with 10% BaSO4 and 1% TiO2; Polystyrene female luer lock hub. Dimensions: 10 cm needle length, 4F cannula sheath. EO sterilization. Manual operation; no software or electronic components.

Indications for Use

Indicated for guidewire introduction during percutaneous gastrointestinal procedures in patients requiring percutaneous endoscopic access.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• LumiLoc Safety Introducer Needle (K070449)
• Modified TFX Medical Safety Needle with Introducer (K043258)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. |
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**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) | <div> <span> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </span> <span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </span> </div> |
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## 510(k) Summary

| Date Prepared: | March 15, 2018 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Aspire Bariatrics, Inc.<br>3200 Horizon Drive,<br>Suite 100<br>King of Prussia, Pa 19406<br>Phone [phone]<br>Fax [phone] |
| Company Contact: | Monica Ferrante, DPA<br>VP Regulatory & Quality<br>Email [e-mail]<br>Phone [phone] |
| 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<br>K043258 Teleflex Medical, TFX Medical Safety Needle with Introducer |
| Device Description: | The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable<br>product used to provide initial percutaneous access. It is comprised of a stainless<br>steel needle with a plastic sheath to be used in guidewire placement during<br>percutaneous endoscopic procedures. The needle is used once the stomach is<br>insufflated and the site verified through trans-illumination and visualization of<br>finger indentation through the endoscope. The introducer needle is similar in<br>design to other needles currently on the market for the same intended purpose.<br>The dimensions of this device fall within the range of currently marketed<br>introducer needles with the same intended use, and the materials are similar in<br>that the needle is made from stainless steel and the other components are<br>plastics. The device also incorporates a female luer lock hub in the design, also |

provided in the predicate devices.

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#### 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<br>International, Inc. | Teleflex Medical |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Introducer Needle | LumiLoc Safety Introducer<br>Needle | Modified TFX Medical Safety<br>Needle with Introducer |
| 510(k) | TBD | K070449 | K043258 |
| Regulation | 876.5980 | 876.5980 | 876.5980 |
| Product Code | KNT | KNT | KNT |
| Indications for<br>Use | The Aspire Introducer Needle<br>is intended to be used for<br>guidewire introduction during<br>percutaneous gastrointestinal<br>procedures. | The LumiLoc Safety Introducer<br>Needle is intended to be used<br>for percutaneous procedures<br>utilizing a sheathed introducer<br>trocar/needle for guidewire<br>introduction during<br>percutaneous gastrointestinal<br>procedures.<br><br>LumiLoc Safety Introducer<br>Needle's engineered integral<br>safety guard is passively<br>activated by the clinician upon<br>removal of the trocar/needle<br>from the introducer sheath.<br><br>The LumiLoc Safety Introducer<br>Needle helps to reduce the risk<br>of accidental trocar/needlestick<br>injuries by locking a safety guard<br>over the trocar/needle tip. | The Modified TFX Medical<br>Safety Needle with<br>Introducer is intended to be<br>used for guidewire<br>introduction during<br>gastrointestinal procedures<br>such as PEG (Percutaneous<br>Endoscopic Gastrostomy),<br>PEJ (Percutaneous<br>Endoscopic Jejunostomy) or<br>other endoscopic<br>gastrointestinal procedures<br>requiring placement of a<br>guidewire. |
| Materials | Needle: 17 gauge passivated<br>304 stainless steel<br><br>Female Luer Needle Hub:<br>Polystyrene Clear<br><br>Cannula Sheath: High Density<br>Polyethylene with 10% BaSO4<br>and 1% TiO White | Needle: stainless steel<br><br>Needle Hub: colored translucent<br><br>Cannula Sheath: not described | Needle: stainless steel<br><br>Luer Hub: not described<br><br>Cannula Sheath:<br>polypropylene (previously<br>High Density Polyethylene) |
| | Cannula Hub/T Handle: High<br>Density Polyethylene White<br>Protective Sleeve: Low<br>Density Polyethylene Clear | Female Luer Cannula Hub:<br>colored translucent<br>Safety Needle: Seldinger shield | Cannula Hub: not described<br>Safety Needle: not described |
| Needle Length | 10 cm needle plus bevel<br>length of 0.5 cm | Not described | lengths between<br>2.50" - 4.0"<br>(6.35 - 10.16 cm) |
| Needle Bevel<br>Indicator | Yes, arrow on Trocar Needle<br>Hub | Yes, bevel up indicator on Trocar<br>Needle Hub | Not described |
| Needle Gauge | 17 Gauge<br>(.058" OD x .048" ID) stainless<br>steel needle with female luer<br>lock hub | Not described | 14 - 18 Gauge |
| Cannula Sheath<br>French size | 4 F<br>(.067±.002" ID)<br>10 cm long cannula sheath<br>with over molded "T" handle | Not described | 2F - 6F sizes |
| Cannula Sheath | Non-peelable | Non-peelable | Non-peelable |
| Guidewire size | Guidewire < 0.059"<br>(<1.49mm) | Not described | guidewires from 0.015" -<br>0.052"<br>(0.38 - 1.32mm) |
| Protective<br>sheath | 11.8 cm clear protective<br>sheath (covers and protects<br>cannula and needle prior to<br>use) | Safety Needle Seldinger shield | Safety Needle with passive<br>sharps protection |
| Sterile | Yes EO | Yes - not specified | Yes |

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## 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. ●

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#### 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.