APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR

K041131 · Apple Medical Corp. · GCJ · May 13, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041131
• Device Name: APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
• Applicant: Apple Medical Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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.

Device Story

The Apple Medical OB Mobius Elastic Retractor is a manual surgical instrument used during laparotomy procedures. It consists of an internal o-ring and an external quad-ring connected by a cylindrical sleeve. During use, the internal o-ring is manually collapsed, inserted through the abdominal incision, and allowed to spring open against the parietal peritoneum. The external quad-ring is then pulled upward to place the sleeve in tension; the operator rolls the external ring down the sleeve until it sits firmly against the skin. The radial force of the two rings retracts the abdominal wall to a circular geometry. The device is used in an operating room setting by surgeons to facilitate access to the peritoneal cavity while protecting the wound edges from contamination.

Clinical Evidence

No clinical data; substantial equivalence established through mechanical properties testing.

Technological Characteristics

Manual abdominal retractor consisting of an internal o-ring, external quad-ring, and a cylindrical sleeve. Operates via radial force to maintain incision geometry. No energy source or software components.

Indications for Use

Indicated for use to assist in laparotomy procedures, providing incision retraction and protection against wound contamination during open surgery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Alexis™ Wound Retractor (K031889)
• Mobius Elastic Retractor (K014005)

Submission Summary (Full Text)

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## 510(k) Summary

| Sponsor | John C. Pulford<br>Apple Medical Corporation<br>28 Lord Road, Unit 135<br>Marlboro, MA 01752 | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Date of summary | April 7, 2004 | |
| Device Trade Name | Apple Medical OB Mobius Elastic Retractor | |
| Common Name | Abdominal Retractor | |
| Classification Name | Surgical Drape<br>21 CFR §878.4370 ProCode KKX | Endoscope and Accessories<br>21 CFR §876.1500, ProCode GCJ |
| Predicate Devices | Alexis™ Wound Retractor<br>K031889 | Mobius Elastic Retractor<br>K014005 |
| Description | The Apple Medical OB Mobius Elastic Retractor is used for<br>laparotomy procedures where a transverse suprapubic incision is made<br>in the abdominal wall allowing access to the peritoneal cavity. Once<br>the incision is made, the internal o-ring is manually collapsed and<br>inserted through the abdominal incision where it is allowed to spring<br>open against the parietal peritoneum. The external quad-ring is then<br>pulled upward placing the cylindrical sleeve in tension and the operator<br>rolls the ring down the sleeve until the ring sits firmly against the skin.<br>The radial force of the two rings act to retract the abdominal wall to the<br>desired circular geometry. | |
| Intended Use | The Apple Medical OB Mobius Elastic Retractor is indicated for use to<br>assist in laparotomy procedures. It is intended to provide incision<br>retraction and to protect against wound contamination during open<br>surgery. | |
| Technological Characteristics | The subject device has the same technological characteristics as the<br>predicate devices. The only changes involve a change to the<br>dimensions and labeling for the OB Mobius device. These changes do<br>not affect the safety and effectiveness of the device. | |
| Testing | The Apple Medical OB Mobius Elastic Retractor has been shown to be<br>substantially equivalent to the predicate Alexis™ device through<br>mechanical 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 [phone] or [phone] 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