(13 days)
The Apple Medical OB Mobius Elastic Retractor is indicated for use to assist in laparotomy procedures. It is intended to provide incision retraction and to protect against wound contamination during open surgery.
The Apple Medical OB Mobius Elastic Retractor is used for laparotomy 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 o-ring is manually collapsed 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. The radial force of the two rings act to retract the abdominal wall to the desired circular geometry.
The provided text is a 510(k) summary for the Apple Medical OB Mobius Elastic Retractor. It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical properties testing. However, it does not contain information typically found in acceptance criteria or a study proving the device meets said criteria for an AI/ML medical device.
The document states:
- "The Apple Medical OB Mobius Elastic Retractor has been shown to be substantially equivalent to the predicate Alexis™ device through mechanical properties testing."
- "The subject device has the same technological characteristics as the predicate devices. The only changes involve a change to the dimensions and labeling for the OB Mobius device. These changes do not affect the safety and effectiveness of the device."
This indicates a comparison to a predicate device, which is a common pathway for 510(k) clearance, rather than a detailed study with acceptance criteria and performance metrics as would be typical for an AI/ML device.
Therefore, many of the requested details about acceptance criteria, study design, and AI-specific metrics (like sample size for test/training sets, expert ground truth, MRMC studies) are not available in this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Alexis™ Wound Retractor, K031889) based on mechanical properties. | "The Apple Medical OB Mobius Elastic Retractor has been shown to be substantially equivalent to the predicate Alexis™ device through mechanical properties testing." |
| No adverse impact on safety and effectiveness due to changes in dimensions and labeling. | "The only changes involve a change to the dimensions and labeling for the OB Mobius device. These changes do not affect the safety and effectiveness of the device." |
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This is a mechanical device, not an AI/ML device relying on "test sets" of data. The "testing" referred to is mechanical properties testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. This is a mechanical device and does not involve establishing ground truth from experts in the way an AI/ML device would.
4. Adjudication method for the test set
- Not applicable/Not provided. No "test set" or human adjudication is described for a mechanical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is a mechanical device, not an AI/ML device. MRMC studies are not relevant here.
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.
7. The type of ground truth used
- Not applicable. For this mechanical device, the "ground truth" for proving substantial equivalence relates to its physical and mechanical properties being comparable to the predicate device, not to diagnostic outcomes.
8. The sample size for the training set
- Not applicable/Not provided. This is a mechanical device, not an AI/ML device using a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is a mechanical device, not an AI/ML device.
In summary, the provided document details the regulatory clearance of a physical medical device (an abdominal retractor) based on its substantial equivalence to a predicate device, supported by mechanical properties testing. It does not provide the kind of information requested for an AI/ML device's acceptance criteria and validation study.
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510(k) Summary
| Sponsor | John C. PulfordApple Medical Corporation28 Lord Road, Unit 135Marlboro, MA 01752 | |
|---|---|---|
| Date of summary | April 7, 2004 | |
| Device Trade Name | Apple Medical OB Mobius Elastic Retractor | |
| Common Name | Abdominal Retractor | |
| Classification Name | Surgical Drape21 CFR §878.4370 ProCode KKX | Endoscope and Accessories21 CFR §876.1500, ProCode GCJ |
| Predicate Devices | Alexis™ Wound RetractorK031889 | Mobius Elastic RetractorK014005 |
| Description | The Apple Medical OB Mobius Elastic Retractor is used forlaparotomy procedures where a transverse suprapubic incision is madein the abdominal wall allowing access to the peritoneal cavity. Oncethe incision is made, the internal o-ring is manually collapsed andinserted through the abdominal incision where it is allowed to springopen against the parietal peritoneum. The external quad-ring is thenpulled upward placing the cylindrical sleeve in tension and the operatorrolls the ring down the sleeve until the ring sits firmly against the skin.The radial force of the two rings act to retract the abdominal wall to thedesired circular geometry. | |
| Intended Use | The Apple Medical OB Mobius Elastic Retractor is indicated for use toassist in laparotomy procedures. It is intended to provide incisionretraction and to protect against wound contamination during opensurgery. | |
| Technological Characteristics | The subject device has the same technological characteristics as thepredicate devices. The only changes involve a change to thedimensions and labeling for the OB Mobius device. These changes donot affect the safety and effectiveness of the device. | |
| Testing | The Apple Medical OB Mobius Elastic Retractor has been shown to besubstantially equivalent to the predicate Alexis™ device throughmechanical properties testing. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Apple Medical Corporation c/o Mr. Robert Mosenkis President Citech 5200 Butler Pikc Plymouth Meeting, Pennsylvania 19462
Re: K041131
Trade/Device Name: Apple Medical OB Mobius Elastic Retractor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 28, 2004 Received: April 30, 2004
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your weekermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosuly to regary the Medical Device Amendments, or to conninered provide in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). alla Cosmetic Too (1107 that to nevice, subject to the general controls provisions of the Act. The r ou may, dierelove, mains of the Act include requirements for annual registration, listing of general controls proficious practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (scc above) into either class II (Special Controls) or class III (PMA), it If your de vice is ones additional controls. Existing major regulations affecting your device can may be subject to back as a lateral 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 I least be advised that I DTP issualles over device complies with other requirements of the Act that I DTT has made a coulations administered by other Federal agencies. You must of any i cacal statutes und regarantins sincluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for at and quality by sontrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Robert Mosenkis
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter notification. The FDA finding of substantial equivalence of your device to a legally prematication of the device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific as not any 101) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
iriam C. Provost
Colia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Apple Medical OB Mobius
Indications for Use:
The Apple Medical OB Mobius is indicated for use to assist in laparotomy procedures. It
he supportunities in this works in and to protect against wound contamination The Apple Medical OB Mobius is Indicated for use to assisted in p
is intended to provide incision retraction and to protect against wound contamination during open surgery.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (
) (PLEASE DO NOT WRITE OR VEEDED) OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page | of |
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
002
§ 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.