Aspire Venting Tube

K182248 · Aspire Bariatrics, Inc. · KNT · Nov 13, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K182248
• Device Name: Aspire Venting Tube
• Applicant: Aspire Bariatrics, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Aspire Venting Tube is intended for use in adult patients who require gastric decompression.

Device Story

Aspire Venting Tube is a gastrostomy tube providing secured access to the stomach via initial placement or formed stoma; facilitates gastric decompression. Device consists of gastric segment with five venting holes, internal bumper, and stoma segment. Used in clinical settings; operated by healthcare professionals. Gastric segment traverses stomach toward fundus; holes allow decompression. Device is MR safe and radiopaque. Benefits include effective gastric decompression for patients requiring such intervention.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1:2009), EtO sterilization validation, shelf-life testing (accelerated and real-time), and mechanical verification (bond strength, bumper pull-through, leak test, and flow test).

Technological Characteristics

Medical grade silicone construction. Features internal bumper and gastric segment with five venting holes. Dimensions: 15.2cm x 30F gastric segment, 25mm bumper, 25cm stoma segment (26F OD, 6mm ID). Radiopaque (BaSO4). MR Safe. Sterilized via Ethylene Oxide (EtO).

Indications for Use

Indicated for adult patients requiring gastric decompression.

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

• Ponsky Non-Balloon Replacement Gastrostomy Tube (K103109)
• EnTake PEG Standard (K061021)

Submission Summary (Full Text)

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November 13, 2018

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

Re: K182248

> Trade/Device Name: Aspire Venting Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: August 15, 2018 Received: August 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 mav, 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 avare 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. 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) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jeffrey W. Cooper -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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## Indications for Use

510(k) Number (if known) K182248

Device Name Aspire Venting Tube

Indications for Use (Describe)

The Aspire Venting Tube is intended for use in adult patients who require gastric decompression.

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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### 510(k) Summary

| Date Prepared: | November 13, 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 Venting Tube |
| Classification Name: | Gastrointestinal tube and accessories |
| Classification Regulation: | 21 CFR 876.5980 |
| Product Code: | KNT |
| Regulatory Class: | II |
| Review Panel: | Gastroenterology and Urology |
| Common Name: | Gastrostomy tube |
| Predicate Devices: | *K103109 Bard Access Systems, Inc., Ponsky Non-Balloon Replacement<br>Gastrostomy Tube (*primary predicate device)<br>K061021 ConMed Endoscopic, EnTake PEG Standard |
| Device Description: | The Aspire Venting Tube is a gastrostomy tube used to provide secured access to<br>the stomach through the initial placement or a formed stoma. The tube is<br>designed to facilitate decompression. |
| Indications for Use: | The Aspire Venting Tube is intended for use in adult patients who require gastric<br>decompression. |

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#### Comparison to Predicates:

| Submitter | Aspire Bariatrics, Inc. | Bard Access Systems, Inc | ConMed Endoscopic |
|------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Product Name | Venting Tube | Ponsky Non-Balloon<br>Replacement Gastrostomy Tube | EnTake PEG Standard |
| | | (primary predicate device) | |
| 510(k) | TBD | K103109 | K061021 |
| Regulation | 876.5980 | 876.5980 | 876.5980 |
| Product Code | KNT | KNT | KNT |
| Indications for<br>Use | The Aspire Venting Tube is<br>intended for use in adult<br>patients who require gastric<br>decompression. | For percutaneous placement of<br>a long-term replacement<br>gastrostomy feeding and/or<br>decompression device into an<br>established stoma. | For percutaneous placement of<br>a long-term initial -placement<br>feeding and/or decompression<br>device. |
| | | | |
| | | | |
| Materials | Medical Grade Silicone | Medical Grade Silicone | Medical Grade Silicone |
| Radiopacity | Radiopaque w/ BaSO4 | Radiopaque | Not Specified |
| MRI | MR Safe | Not specified | Not Specified |
| French Size | 26Fr | 12Fr to 24Fr | 14Fr to 24Fr |
| Stoma Length | 25 cm | 15 cm | 10 cm |
| Gastric Segment | Internal Bumper and gastric<br>tail with holes to facilitate<br>decompression | Internal Bumper | Internal Bumper (dome) |
| Placement/<br>Removal | PEG Pull /<br>Endoscopic Removal | Placement only through existing<br>stoma tract /<br>Traction or Endoscopic Removal | PEG Pull or Push /<br>Traction or Endoscopic Removal |
| | | | |
| Sterile | Yes EO | Yes - EO | Yes |

Technological Characteristics: The Aspire Venting Tube is similar to a standard PEG tube with the addition of a gastric portion to the tube which traverses the stomach and lies upwards towards the fundus. The gastric portion of the tube contains holes along its length to facilitate decompression of the stomach. The Aspire Venting Tube is MR Safe and radiopaque.

> The Aspire Venting Tube is comprised of a Gastric segment (15.2cm x 30F) with five venting holes; a Bumper (25mm diameter); and a stoma segment (L: 25cm, OD: 26F, ID: 6mm).

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All components are made with materials known for safe and effective long-term use in medical devices, and minor technological differences do not introduce new questions of safety and effectiveness.

- Product Material: The Aspire Venting Tube is manufactured from medical grade Silicone
Biocompatibility Testing: The Aspire Venting Tube 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 Venting Tube 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. The following is a list of testing performed:
- EtO Sterilization
- Shelf Life
- Accelerated o
- Real Time O
- Verification Testing
- O Bond Strength (Pull Test)
- Bumper Pull Through O
- O Leak Test
- O Flow Test

Clinical Testing: Not applicable to this device.

Conclusion:

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