(104 days)
The Airlift Jr.™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery. The Airlift Jr.™ Balloon Retraction System is used in conjunction with the Laparoliff™ previously cleared under premarket notification K921103 September 9, 1993. The predicate device (Airlift™ Balloon Retraction System) has applications in laparoscopic surgery and is indicated and may be used as an alternative to insufflation for retracting organs and creating a working cavity for laparoscopic surgery. The predicate device is also used in conjunction with the Laparoliff™ .
The Airlift Jr.™ Balloon Retraction System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
The Airlift Jr.™ Balloon Retraction System is a single-use device which consist of an inflatable balloon, balloon sheath, tether and scrap, inflation bulb, and an attachment assembly which includes a connector drape and tool holder. The Airlift Jr.™ Balloon Retraction System is provided sterile and is developed to be used in conjunction with an Origin Laparolift Retraction System. This device is used to lift and retract organs and tissues to provide a space for endoscopic surgery without the use of gas insufflation.
The retraction of organs and tissues is achieved by first making a small incision then inserting the Airlift Balloon device. The Airlift Balloon is then attached to the Laparolift (mechanical distention arm) by means of the attachment assembly (tool holder and connector drape). The Laparolift is used to lift the Airlift Balloon device, and therefore the organs and tissues are raised to the height typically achieved by gas insufflation thus creating a working cavity for surgery. This function is equivalent to those described for the predicate device: Airlift™ Balloon Retraction System K942678, same as (Lifting Distention Balloon System, the predicate device will be refered to hence forth as Airlift™ Balloon Retraction System). The new device: Airlift™ Jr. has a balloon size of 4.1 inches deployed. The predicate device: Airlift™ Balloon Retraction System has a balloon size of 5.4 inches deployed. (See comparable chart on page 16-17).
This document is a 510(k) summary for the ORIGIN® Medsystems, Inc. Airlift Jr.™ Balloon Retraction System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a dedicated study with defined performance metrics.
Therefore, many of the requested elements (acceptance criteria, specific study details like sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and detailed ground truth establishment) are generally not applicable or not explicitly provided in a 510(k) summary focused on substantial equivalence for this type of device.
Here's an analysis based on the provided text, indicating which elements are not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable/Not Provided: This 510(k) summary does not define specific quantitative acceptance criteria or report performance metrics against such criteria in the way a clinical trial or device performance study would for a new technology seeking to prove efficacy or diagnostic accuracy. The basis for substantial equivalence is primarily on material, technological characteristics, and intended use similarity to a predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
Not Applicable/Not Provided: No "test set" in the context of a performance study is mentioned. The submission relies on demonstrating similarity to a previously cleared device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not Applicable/Not Provided: Ground truth establishment by experts for a test set is not part of this type of submission.
4. Adjudication Method for the Test Set
Not Applicable/Not Provided: No adjudication method is mentioned as there is no "test set" or performance evaluation described.
5. If a Multi Reader Multi Case (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
Not Applicable/Not Provided: This device is a mechanical retraction system, not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Not Provided: This is a mechanical device, not an algorithm. Standalone performance as described is not relevant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not Applicable/Not Provided: The concept of "ground truth" for proving diagnostic or predictive accuracy is not applicable to this device's submission. The "truth" in this context is the predicate device's established safety and effectiveness.
8. The Sample Size for the Training Set
Not Applicable/Not Provided: There is no "training set" as this is not a learning algorithm or AI device.
9. How the Ground Truth for the Training Set was Established
Not Applicable/Not Provided: Not applicable for the reasons mentioned above.
Summary of the 510(k) Submission's Approach to Substantial Equivalence:
The submission focuses on the following to establish substantial equivalence:
- Predicate Device: The ORIGIN Airlift™ Balloon Retraction System (K942678).
- Identical Characteristics: The Airlift Jr.™ shares "identical material, and technological characteristics" as the predicate device, despite a smaller balloon size (4.1 inches vs. 5.4 inches for the predicate).
- Identical Intended Use: Both devices are for retracting organs and tissues to create a working cavity for endoscopic/laparoscopic surgery as an alternative to gas insufflation, used in conjunction with the Laparolift™.
- Device Description:
- Components: Single-use device consisting of an inflatable balloon, balloon sheath, tether and strap, inflation bulb, and an attachment assembly (connector drape and tool holder).
- Function: Inserted through a small incision, attached to the Laparolift, which then lifts the balloon and thus organs/tissues to create a surgical cavity.
- Materials: Patient contact components (Inflation Balloon, Containment Sheath, Tether and Strap, Tube Inflation) are made of polyurethane and/or polyurethane-coated nylon, which are materials already cleared for biocompatibility in existing ORIGIN products (including the predicate device).
This 510(k) relies on the premise that since the Airlift Jr.™ is fundamentally the same in intended use, materials, and technological characteristics as the already cleared predicate device, it is equally safe and effective, and therefore does not require new, extensive clinical studies to establish "acceptance criteria" or "performance."
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.