APPLE MEDICAL MOBIUS ELASTIC RETRACTOR

K014005 · Apple Medical Corp. · GCJ · Feb 15, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K014005
• Device Name: APPLE MEDICAL MOBIUS ELASTIC RETRACTOR
• Applicant: Apple Medical Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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.

Device Story

The Mobius Elastic Retractor is a surgical device used during minilaparotomy to retract the abdominal wall and protect the incision site from contamination. It consists of a cylindrical sleeve with two rings. The internal ring is inserted through the incision and springs open against the parietal peritoneum; the external quad-ring is then pulled upward to place the sleeve in tension and rolled down to sit firmly against the skin. The external ring features a 'cruciform' cross-section with four points for improved tactile manipulation and is fabricated as a Mobius strip to provide a preset outward torque. These features enhance ease of deployment compared to the predicate device while maintaining equivalent resistance to rollback. The device is used by surgeons in an operating room setting to provide circular geometry for the incision, facilitating access to the peritoneal cavity.

Clinical Evidence

Evidence includes bench testing and a porcine model study. Bench testing by Intertek Testing Services compared the subject device to the predicate, finding the subject device easier to operate with no significant difference in rollback resistance. A porcine model study conducted by Dr. Marco Pelosi independently confirmed these findings, noting superior ease of operation for the subject device and equivalent resistance to rollback compared to the predicate.

Technological Characteristics

The device consists of a cylindrical sleeve and two rings. The external ring is a quad-ring with a 'cruciform' cross-section, fabricated as a Mobius strip to impart outward torque. The device functions via mechanical radial force to retract the abdominal wall. It is a non-powered, manual surgical instrument.

Indications for Use

Indicated for patients undergoing minilaparotomy procedures requiring abdominal wall 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

• Protractor Retractor (K954824)

Submission Summary (Full Text)

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# FEB 1 5 2002

Apple Medical Corp. 510(k) Premarket Notification

K014005

October 30, 2002 Mobius Elastic Retractor

## 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Apple Medical Corp. is required to sumit 1 uisdailt to 212(1)(3)(1) of the 1 000, Brog ... adequate summary of any information respecting safety and will this I remarks i Normation will be made available upon request of any person." Apple Medical chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Apple Medical Mobius Elastic Retractor Trade Name: Contact: John Pulford Apple Medical Corporation Owner/Operator: Phone: [phone] Lord Road, Unit 135 Fax: [phone] Marlboro, MA 01752 (Submitter) Registration # 1221923 Manufacturer/ GeoTec. Inc. Sterilization Site: 2800 Post Road, Unit 3 Warwick, RI 02886 Professional Contract Sterilization 40 Myles Standish Boulevard Taunton, Massachusetts 02780 Abdominal Retractor Device Generic Name: According to Section 513 of the Federal Food, Drug , and Classification: Cosmetic Act, the device classification is Class II, Performance Standards (21 CFR 878.4370). Protractor Retractor Predicate Device: Marketed by: Dexterity Surgical, Inc. 1495 Hembree Rd., Suite 700 Rosewell, GA 30076 K954824

### Product Description:

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

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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.

### Indications for Use:

The Apple Medical Mobius Elastic Retractor is an abdominal retractor used to assist in minilaparotomy The Apple Medical Incords Encision retraction and to protect against wound contamination during open surgery.

### Performance Testing:

Substantial equivalence for the proposed Apple Medical Mobius Elastic Retractor is based on a comparison the Substantal equivalence for us proposed rippio of operation as compared to the predicate device. It has of natorials, design, specifically equivalent or superior to the predicate through bench testing, survey and animal studies.

Both the proposed Apple devices and the predicate Dexterity device were bench tested for equivalence by Intertek Testing Services (ITS). ITS independently found that the Apple device was easier to operate as intended than the predicate and that there was no significant difference in either one of the devices resistance to rollback (please see Section 4).

Both the proposed Apple device and the predicate Dexterity device were comparison tested for operability Dour the proposed Apple device and the products to be porcine model. Dr. Pelosi independently found that by Dr. Marco Felost at Bu Piner Diencelous at and than the predicate and that there was no significant difference in either one of the devices resistance to rollback (please see section 4).

#### Conclusion:

Based on the indications for use and technological/design characteristics, the Apple Medical Mobius Elastic Retractor device has been shown to be safe and effective for it intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

Apple Medical Corporation c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462

Re: K014005

K014005
Trade/Device Name: Apple Medical Mobius Elastic Retractor
Trade/Device Name: Apple Medical Mobius Elastic Retractor Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 30, 2002 Received: January 31, 2002

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Securitied the levice is substantially equivalent (for the indications
referenced above and have determined the devices as subsess marketed in interstat referenced above and nave delemined the devices marketed in interstate for use stated in the enclosure) to legally inanced technical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the arounisions of the Federal Food. Drue commerce prior to May 28, 1976, the elaculting of the Federal Food, Drug, devices that have been reclassified in accoluance who were as a movel application (PMA).
and Cosmetic Act (Act) that do not require approval assessor specialions of the Act. and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, subject to the ganted registration, listing of
general controls provisions of the Act include required misbranding and general controls provisions of the Act mender requirements of the many and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) min claired in cregulations affecting your device can
may be subject to such additional controls. Title of to 808 In addition FDA may be subject to such additional controlist Existing includes In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parth Scharter be found in the Couc of Federal Regarations)
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 Please be advised that FDA s issuality of a substition of the requirements of the Act
that FDA has made a determination that your device Force agencies. You must that FDA has made a decemination that your as rout of echeral agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statures and regulations administer of registration and listing (21
comply with all the Act's requirements, including, but not meating requirements as set comply with all the Act s requirements, moradias and include requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); iabeling (21 CFA Fatt of J, good manantag provinsiale, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the el forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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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) This letter will anow you to begin makemig your advice of your device to a legally
premarket notification. The FDA finding of substantial equivalias and thus, permits vour d premarket notification. The PDA midning of substantial equice 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 and If you desire specific advice for your avited diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please conta additionally 21 CFN Pat 807.10 for mire unstions on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and advertisi Compliance at [phone]. Additionally, for question of 594-4639. Also, please note the your device, picase contact the Offee of remarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket may be obtained from the regulation entitled, "Misoranding of references of proder the Act may be obtained from the Other general information on your responsional 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 yours,

Muriane C. Provost

for Celia 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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# 510(k) Number (if known): K014005

Device Name: Apple Medical Mobius Elastic Retractor

Indications for Use:

The Apple Medical Mobius Elastic Retractor is indicated for use to assist in The Apple Medical Moorus Industry results incision retraction and to minitiaparotoniy provid contamination during open surgery.

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

(Division Sign-Off) Division of Ge a al, Restorative and Neurological Deviees

510(k) Number K014005