(85 days)
The Aspire Venting Tube is intended for use in adult patients who require gastric decompression.
The Aspire Venting Tube is a gastrostomy tube used to provide secured access to the stomach through the initial placement or a formed stoma. The tube is designed to facilitate decompression.
The provided document is a 510(k) premarket notification for a medical device called the "Aspire Venting Tube". This type of document is for demonstrating substantial equivalence to a predicate device, not typically for AI/ML device performance studies. As such, the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable to this document.
The document discusses "Performance Testing" for the device, but this refers to engineering and biocompatibility tests for the physical device itself, not performance of an AI/ML algorithm.
Specifically, the document states:
- "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, Real Time), Verification Testing (Bond Strength (Pull Test), Bumper Pull Through, Leak Test, Flow Test)."
- "Clinical Testing: Not applicable to this device."
Therefore, I cannot provide the requested information from this document because it pertains to a physical medical device and its predicate equivalence, not an AI/ML-driven diagnostic or treatment support system.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.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 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 ReplacementGastrostomy Tube (*primary predicate device)K061021 ConMed Endoscopic, EnTake PEG Standard |
| Device Description: | The Aspire Venting Tube is a gastrostomy tube used to provide secured access tothe stomach through the initial placement or a formed stoma. The tube isdesigned to facilitate decompression. |
| Indications for Use: | The Aspire Venting Tube is intended for use in adult patients who require gastricdecompression. |
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Comparison to Predicates:
| Submitter | Aspire Bariatrics, Inc. | Bard Access Systems, Inc | ConMed Endoscopic |
|---|---|---|---|
| Product Name | Venting Tube | Ponsky Non-BalloonReplacement 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 forUse | The Aspire Venting Tube isintended for use in adultpatients who require gastricdecompression. | For percutaneous placement ofa long-term replacementgastrostomy feeding and/ordecompression device into anestablished stoma. | For percutaneous placement ofa long-term initial -placementfeeding and/or decompressiondevice. |
| 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 gastrictail with holes to facilitatedecompression | Internal Bumper | Internal Bumper (dome) |
| Placement/Removal | PEG Pull /Endoscopic Removal | Placement only through existingstoma tract /Traction or Endoscopic Removal | PEG Pull or Push /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.
§ 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.