(72 days)
The Apple Medical Mobius Elastic Retractor is indicated for use to assist in minilaparotomy incision retraction and to protect against wound contamination during open surgery.
The Apple retractor is used for minilaparotomy procedures where a transverse suprapubic incision is made in the abdominal wall allowing access to the peritoneal cavity. Once the incision is made, the internal om and aboundar wan and inserted through the abdominal incision where it is allowed to spring open against the parietal peritoneum. The external quad-ring is then pulled upward placing the cylindrical sleeve in tension and the operator rolls the ring down the sleeve until the ring sits firmly against the skin (ref. Directions for Use). The radial force of the two rings place the sleeve material in tension and the sleeve now acts to retract the abdominal wall to the desired circular geometry. Both the proposed Apple device and the predicate Dexterity device function in an identical way to retract the abdomen. The difference in the two devices is in the ergonomical efficiency of deploying the two devices. The external quad-ring of the proposed Apple device was engineered to have more points around the 360 degree circumference for increased tactile manipulation ability (the predicate has two points in an "oblate spheroid" type of crosssection and the Apple device has four points in a truncated astroid, or "cruciform", cross-section). Further, the Apple device's external quad-ring is formed into a mobius strip during fabrication thus imparting a preset outward torque on the device. This "mobius" type of fabrication coupled with the four points for tactile feel, results in an external quad-ring which is easier to manipulate into the desired position than is the recircate device while still possessing an equivalent resistance to rollback as the predicate.
Here's an analysis of the provided text regarding the Apple Medical Mobius Elastic Retractor, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) Premarket Notification summary. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial data for novel devices. Therefore, the information related to detailed acceptance criteria, specific performance metrics, and rigorous study methodologies (like blinding, statistical power calculations, etc.) is less detailed than what might be found for a New Drug Application or a Class III medical device PMA.
Based on the document:
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" in this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device (Dexterity Surgical, Inc.'s abdominal retractor, K954824) in terms of safety and effectiveness, particularly its mechanism of operation.
| Acceptance Criteria (Implicit) | Reported Device Performance (Apple Medical Mobius Elastic Retractor) |
|---|---|
| Ease of Operation | Easier to operate as intended than the predicate. |
| Resistance to Rollback | No significant difference compared to the predicate. |
| Functionality | Functions in an identical way to retract the abdomen. |
| Safety and Effectiveness | Shown to be safe and effective for its intended use. |
Study Details
The document describes several tests conducted to demonstrate equivalence:
Bench Testing:
- Sample Size and Data Provenance: Not explicitly stated. The testing was performed by Intertek Testing Services (ITS), an independent entity.
- Number of Experts and Qualifications: Not applicable for bench testing.
- Adjudication Method: Not applicable for bench testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. Bench testing does not involve human readers.
- Standalone Performance: Yes, the device's mechanical properties were evaluated independently and in comparison to the predicate.
- Type of Ground Truth: Direct measurement and comparative assessment of mechanical properties and ease of use in a controlled laboratory setting.
- Sample Size for Training Set: Not applicable for bench testing.
- Ground Truth for Training Set: Not applicable for bench testing.
Animal Study (Porcine Model):
- Sample Size and Data Provenance: Not explicitly stated for the animal study. The study was conducted by Dr. Marco Pelosi at Bu Piner Diedicelous (likely a misspelling/OCR error of a clinic or institution).
- Number of Experts and Qualifications: Dr. Marco Pelosi is mentioned as independently finding the results. His specific qualifications are not detailed beyond "Dr."
- Adjudication Method: Not explicitly stated, but implies the single expert's findings.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This was an in-vivo comparison study, likely observational or involving direct manipulation by the surgeon.
- Standalone Performance: Yes, the device's operability and rollback resistance were evaluated in a living system.
- Type of Ground Truth: Direct observation and assessment of the device's performance (operability, resistance to rollback) within the porcine model by a surgeon.
- Sample Size for Training Set: Not applicable. This was an evaluation/test study.
- Ground Truth for Training Set: Not applicable.
Survey (mentioned but not detailed):
The document mentions "survey" as a method used, but provides no details on its methodology, sample size, or findings. Without further information, it's impossible to describe the specifics of this "survey."
Summary of Approach:
The overall approach to demonstrating substantial equivalence for this Class II abdominal retractor relied on:
- Bench testing: To compare the physical and mechanical characteristics, including "ergonomical efficiency" (ease of deployment) and "resistance to rollback."
- Animal study (porcine model): To confirm operability and resistance to rollback in a biological context.
- Comparison to Predicate Device: The key was to show that the Apple Medical Mobius Elastic Retractor performs equivalently or superiorly to the legally marketed predicate device (K954824) for the specified indications for use. The differences in design (quad-ring, mobius strip fabrication) were presented as improvements in "ergonomical efficiency" without compromising key safety/performance parameters like rollback resistance.
The absence of detailed statistical results, blinding, or human reader effectiveness studies is typical for 510(k) submissions of this nature, especially for a Class II device that is demonstrating equivalence to a well-established technology.
§ 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.