LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM

K080158 · Lb Medical LLC · FZW · May 2, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080158
• Device Name: LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
• Applicant: Lb Medical LLC
• Product Code: FZW · General, Plastic Surgery
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.

Device Story

Device is a manual surgical elevator featuring a distal inflatable balloon component; used in orthopaedic or general surgery. Surgeon inserts thin metal probe into tissue; inflates balloon with saline via manual syringe system with integral pressure gauge to elevate or expand tissue. Balloon is non-compliant and expands unidirectionally. Device provides mechanical assistance for tissue access, such as in carpal tunnel release. Used in clinical/surgical settings by physicians. Benefits include controlled tissue elevation/expansion during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing and biocompatibility assessment of balloon materials.

Technological Characteristics

Manual surgical elevator; thin grooved metal probe; distal non-compliant semi-round inflatable balloon; manual saline inflation system with integral pressure gauge; unidirectional expansion; non-powered.

Indications for Use

Indicated for use as a manual elevator in orthopaedic or general surgery, including access to the carpal tunnel region during carpal tunnel release procedures.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Elevator/Probe/Groove Director/Freer (Preamendment)
• KyphX Inflatable Bone Tamp (K041454)
• Acclarent Sinus Balloon Catheter (K061903)
• Spacemaker Surgical Balloon Dissector/Expander (K972109)
• Cook Esophageal Dilation Balloon (K061937)

Submission Summary (Full Text)

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10/13/2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font size.

LB Medical L.L.C. Terry Sheridan Powell Senior Project Manager 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K080158

Trade/Device Name: LB Medical Inflatable Tissue Elevator/Expander System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: FZW

Dear Terry Sheridan Powell:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 3, 2008. Specifically, FDA is updating this SE Letter because FDA has better categorize your device technology under product code FZW.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Deborah Fellhauer, OHT4: Office of Surgical and Infection Control Devices, 301-796-9570, [e-mail].

> Sincerely, Deborah A. Fellhauer -S Deborah A. 2022.10.13 13:11:01 Fellhauer -S -04'00'

Deborah A. Fellhauer RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1

MAY - 2 2008

LB Medical LLC % M Squared Associates, Inc. Terry Sheridan Powell 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K080158

Trade/Device Name: The LB Medical Inflatable Tissue Elevator/Expander System Regulatory Class: Unclassified Product Code: LCJ Dated: April 15, 2008 Received: April 16, 2008

Dear Terry Powell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 - Terry Sheridan Powell

marketed predicate 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

2

Enclosure

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## Indications for Use

510(k) Number (if known): K ೧೯೮) 58

Device Name: The LB Medical Inflatable Tissue Elevator/Expander System

Indications for Use:

The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

3

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Gfr Gr mxm

Division Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K080158

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1080158

MAY - 2 2008

## Section 5: 510(k) Summary

| Sponsor's Name,<br>Address, Phone &<br>Fax: | LB Medical, LLC<br>895 Mohawk Road<br>Franklin Lakes, NJ 07417 |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Terry Sheridan Powell<br>M Squared Associates, Inc., Consultants to LB Medical, LLC<br>(T) 703-562-9800<br>(F) 703-562-9797<br>[e-mail] |
| Date Prepared: | January 18, 2008 |
| Device Trade Name | LB Medical Inflatable Tissue Elevator/Expander System |
| Device Common<br>Name: | Elevator |
| Proposed Class,<br>Classification Name<br>and Number, and<br>Product Code: | Class I (non-exempt)<br>878.4800 - Manual surgical instrument for general use<br>HTE – Elevator |
| Predicate Devices: | Preamendment: Elevator/Probe/Groove Director/Freer K041454: KyphX Inflatable Bone Tamp K061903: Acclarent Sinus Balloon Catheter K972109: Spacemaker Surgical Balloon<br>Disssector/Expander K061937: Cook Esophageal Dilation Balloon |
| Device Description : | The subject device is similar to a traditional elevator, but<br>features a manually inflatable balloon component at the distal<br>end. The balloon is inflated/deflated with saline via a manual<br>inflation syringe system with an integral pressure gauge. |
| Intended Use: | The LB Medical Inflatable Tissue Elevator/Expander System is a<br>surgical tool intended for use as a conventional manual elevator<br>for orthopaedic or general surgery, including use to access the<br>carpal tunnel region during carpal tunnel release procedures. |
| Summary of<br>Technological<br>Characteristics: | The main technological characteristics of the subject device<br>include:<br>A traditional manual elevator: the subject device features a<br>thin grooved metal probe (also called an elevator, grooved<br>director, or freer). As with the predicate KyphX device, this<br>probe houses an uninflated expandable balloon at its distal<br>end. Expandable balloon: the subject device features a semi-round<br>expandable balloon housed at the distal end of the metal<br>elevator. The balloon is made from non-compliant material<br>that expands unidirectionally when inflated. The manually<br>inflatable balloon feature is shared by all the cited post- |
| | amendment 510(k)-cleared predicate devices.<br>Balloon expansion mechanism: the subject device's balloon component is expanded with saline manually using a syringe/catheter assembly with an integral pressure gauge. This feature is shared by several of the cited post-amendment predicate devices. |
| Summary of<br>nonclinical tests | Biocompatibility tests on the balloon material have demonstrated<br>the suitability of the material for its intended purpose. Bench<br>testing of the balloon has demonstrated that its performance<br>characteristics are suitable for its intended use during hand<br>surgery. |
| Summary of clinical<br>tests | Clinical testing was not required to demonstrate the substantial<br>equivalence of the subject device to its predicate devices with<br>regard to materials, design, technological characteristics, or<br>intended use. |
| Conclusions from<br>nonclinical and<br>clinical tests | The subject device features materials that are suitable for the<br>device's intended purpose. The device's balloon mechanism is<br>suitable for its intended uses during hand surgery. |

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2008

LB Medical LLC % M Squared Associates, Inc. Terry Sheridan Powell 901 King Street. Suite 200 Alexandria, Virginia 22314

Re: K080158

Trade/Device Name: The LB Medical Inflatable Tissue Elevator/Expander System Regulatory Class: Unclassified Product Code: LCJ Dated: April 15, 2008 Received: April 16, 2008

Dear Terry Powell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

{7}------------------------------------------------

Page 2 - Terry Sheridan Powell

marketed predicate 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

## Indications for Use

510(k) Number (if known): K 080)S8

Device Name: The LB Medical Inflatable Tissue Elevator/Expander System

Indications for Use:

The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.

Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nel R.P. Gfr. Gr mxm

Division of General. Restorative. and Neurological Devices

Page 1 of 1

510(k) Number K080158