(100 days)
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.
The subject device is similar to a traditional elevator, but features a manually inflatable balloon component at the distal end. The balloon is inflated/deflated with saline via a manual inflation syringe system with an integral pressure gauge.
The provided documents are a 510(k) premarket notification and subsequent administrative change letter for the "LB Medical Inflatable Tissue Elevator/Expander System." This device is a manual surgical instrument and, as such, the submission does not contain the typical acceptance criteria and study data associated with AI/ML-enabled devices or those requiring extensive clinical trials.
The documents indicate that clinical testing was not required to demonstrate substantial equivalence. The device was deemed substantially equivalent based on predicate devices and non-clinical bench testing.
Therefore, many of the requested categories of information for AI/ML devices or devices with rigorous clinical study requirements are not applicable to this submission.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Not Explicitly Stated as "Acceptance Criteria" for Clinical Performance) | Reported Device Performance (from Nonclinical Tests) |
|---|---|
| Biocompatibility: Suitability of balloon material for intended purpose. | Biocompatibility tests on the balloon material have demonstrated the suitability of the material for its intended purpose. |
| Bench Testing (Performance Characteristics): Suitability for intended use during hand surgery. | Bench testing of the balloon has demonstrated that its performance characteristics are suitable for its intended use during hand surgery. |
| Substantial Equivalence: Similar materials, design, technological characteristics, and intended use as predicate devices. | The device was found substantially equivalent to predicate devices based on its materials, design, technological characteristics (e.g., inflatable balloon component, manual inflation), and intended use. Clinical testing was not required. |
Study Details for Demonstrating Substantial Equivalence (Non-Clinical)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively in terms of "test set" for clinical performance, as clinical testing was not required. The "test set" for non-clinical bench testing and biocompatibility is not detailed in the provided summary.
- Data Provenance: The studies were non-clinical (biocompatibility and bench testing). Specific country of origin is not detailed, but the submission is for the U.S. FDA. Retrospective/Prospective is not applicable to these types of non-clinical tests in the context of device approval.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Clinical ground truth from experts was not required given that clinical testing was not performed due to the nature and classification of the device and its predicate equivalence pathway.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Clinical adjudication was not relevant as clinical studies were not conducted.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a manual surgical instrument, not an AI/ML diagnostic or assistive device that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For non-clinical tests, the "ground truth" would be established by standardized testing methods and material science specifications (e.g., ISO standards for biocompatibility, engineering specifications for mechanical performance). No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) based on the provided documents.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device requiring a training set.
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10/13/2022
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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, Deborah.Fellhauer@fda.hhs.gov.
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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,Address, Phone &Fax: | LB Medical, LLC895 Mohawk RoadFranklin Lakes, NJ 07417 |
|---|---|
| Contact Person: | Terry Sheridan PowellM Squared Associates, Inc., Consultants to LB Medical, LLC(T) 703-562-9800(F) 703-562-9797tpowell@msquaredassociates.com |
| Date Prepared: | January 18, 2008 |
| Device Trade Name | LB Medical Inflatable Tissue Elevator/Expander System |
| Device CommonName: | Elevator |
| Proposed Class,Classification Nameand Number, andProduct Code: | Class I (non-exempt)878.4800 - Manual surgical instrument for general useHTE – Elevator |
| Predicate Devices: | Preamendment: Elevator/Probe/Groove Director/Freer K041454: KyphX Inflatable Bone Tamp K061903: Acclarent Sinus Balloon Catheter K972109: Spacemaker Surgical BalloonDisssector/Expander K061937: Cook Esophageal Dilation Balloon |
| Device Description : | The subject device is similar to a traditional elevator, butfeatures a manually inflatable balloon component at the distalend. The balloon is inflated/deflated with saline via a manualinflation syringe system with an integral pressure gauge. |
| Intended Use: | The LB Medical Inflatable Tissue Elevator/Expander System is asurgical tool intended for use as a conventional manual elevatorfor orthopaedic or general surgery, including use to access thecarpal tunnel region during carpal tunnel release procedures. |
| Summary ofTechnologicalCharacteristics: | The main technological characteristics of the subject deviceinclude:A traditional manual elevator: the subject device features athin grooved metal probe (also called an elevator, grooveddirector, or freer). As with the predicate KyphX device, thisprobe houses an uninflated expandable balloon at its distalend. Expandable balloon: the subject device features a semi-roundexpandable balloon housed at the distal end of the metalelevator. The balloon is made from non-compliant materialthat expands unidirectionally when inflated. The manuallyinflatable balloon feature is shared by all the cited post- |
| amendment 510(k)-cleared predicate devices.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 ofnonclinical tests | Biocompatibility tests on the balloon material have demonstratedthe suitability of the material for its intended purpose. Benchtesting of the balloon has demonstrated that its performancecharacteristics are suitable for its intended use during handsurgery. |
| Summary of clinicaltests | Clinical testing was not required to demonstrate the substantialequivalence of the subject device to its predicate devices withregard to materials, design, technological characteristics, orintended use. |
| Conclusions fromnonclinical andclinical tests | The subject device features materials that are suitable for thedevice's intended purpose. The device's balloon mechanism issuitable 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
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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
§ 878.4800 Manual surgical instrument for general use.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.