(231 days)
No
The device description and performance studies focus on mechanical and material properties, sterilization, and biocompatibility, with no mention of AI/ML or related concepts.
No
The device is indicated for aesthetic body contouring (suction lipoplasty), which is not considered a therapeutic indication.
No
The device is indicated for the removal of tissue or fluid during general surgical procedures, specifically suction lipoplasty, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a stainless-steel cannula with a plastic hub, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring." This describes a surgical instrument used in vivo (within the body) for a physical procedure.
- Device Description: The description details a surgical cannula used for aspiration (suction). It connects to a vacuum source and is inserted into the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the MicroAire® PAL® Single-Use Cannulas are surgical instruments, not IVD devices.
N/A
Intended Use / Indications for Use
MicroAire® PAL® Single-Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring.
Product codes (comma separated list FDA assigned to the subject device)
QPB, MUU
Device Description
The MicroAire® PAL Single-Use Cannulas consists of stainless-steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for a standard vacuum (suction) tubing. The MicroAire® Single-Use Cannulas are supplied sterile by the manufacturer through a validated gamma irradiation process. The Single-Use Cannula are offered in various diameters (2.4, 3.0, 4 and 5.0mm diameters), lengths (15, 22, and 30 cm) and with various types of distal fenestrations (Single Port, Mercedes, Bent Flared Mercedes, Double Mercedes, Bent Mercedes, Tri-Port III, Helixed Tri-Port III, Spatula, Multi-Hole, Del Vecchio Track-12).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to demonstrate that the proposed MicroAire PAL Single-Use Cannulas met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.
- . Sterilization validation per ISO 11137 - demonstrates SAL of 10°
- . Biocompatibility testing – Cytotoxicity, Sensitization, Irritation, per ISO 10993 - PASSED
In addition to the guidance and standards testing, the following testing was performed:
- . Mechanical Tensile Testing (fatigue, axial strength, pullout force, pushout force, bend) – Met specifications
- Air leakage and tubing connection force test - Met specifications
- Vacuum pressure testing - Met specification
- Transportation Testing per ASTM D4169 – demonstrates package integrity maintained
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MicroAire Surgical Instruments % Diane Sudduth Sr. Consultant, Regulatory Barile & Associates, Inc. PO Box 5199 Clinton, New Jersey 08809
June 9, 2021
Re: K192694
Trade/Device Name: PAL Single-Use Cannulas Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Diane Sudduth:
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 14, 2020. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
May 14, 2020
MicroAire Surgical Instruments % Diane Sudduth Sr. Consultant, Regulatory Barile & Associates, Inc. PO Box 5199 Clinton, New Jersey 08809
Re: K192694
Trade/Device Name: PAL Single-Use Cannulas Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: April 6, 2020 Received: April 8, 2020
Dear Ms. Sudduth:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
2
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Acting 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
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name MicroAire® PAL® Single-Use Cannulas
Indications for Use (Describe)
MicroAire® PAL® Single-Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510K Summary
PAL® Single-Use Cannulas K 192694
1. Submission Sponsor
MicroAire Surgical Instruments 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 USA Office Phone: (434) 975-8344 Email: glenn.gerstenfeld@microaire.com Contact: Glenn Gerstenfeld Title: Vice President, QA/RA and Compliance Officer
2. Submission Correspondent
Barile & Associates, Inc. PO Box 5199 Clinton, NJ 08809 Office Phone: (561) 305-5075 Email: drsudduth05@gmail.com Contact: Diane Sudduth, Ph.D. Title: Senior Consultant, RA
3. Date Prepared
September 20, 2019 (amended April 21, 2020)
4. Device Identification
| Trade/Proprietary Name: | PAL® Single-Use Cannulas |
|---|---|
| Common/Usual Name: | Cannula |
| Classification Name: | Suction Lipoplasty System |
| Regulation Number: | 21 CFR 878.5040 |
| Product Code: | MUU |
| Device Class: | Class II |
| Classification Panel: | GENERAL AND PLASTIC SURGERY DEVICES |
5
5. Legally Marketed Predicate Device(s)
| Predicate Device: | K171286, MicroAire® PAL System, Multi-Use Cannula |
|---|---|
| Classification Name: | Suction Lipoplasty System |
| Regulation Number: | 21 CFR 878.5040 |
| Product Code: | MUU |
| Classification: | Class II |
| Reference Device: | K981922, MicroAire® Power Aspiration Device (PAD) System Cannula |
| Classification Name: | Suction Lipoplasty System, |
| Regulation Number: | 21 CFR 878.5040 |
| Product Code: | MUU |
| Classification: | Class II |
6. Indication for Use Statement
The MicroAire PAL Single-Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty, for the purpose of aesthetic body contouring.
7. Device Description
The MicroAire® PAL liposuction family of instruments is intended to be used for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Single-Use Cannulas consists of stainless-steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for a standard vacuum (suction) tubing. The MicroAire® Single-Use Cannulas are supplied sterile by the manufacturer through a validated gamma irradiation process. The Single-Use Cannula are offered in various diameters (2.4, 3.0, 4 and 5.0mm diameters), lengths (15, 22, and 30 cm) and with various types of distal fenestrations (Single Port, Mercedes, Bent Flared Mercedes, Double Mercedes, Bent Mercedes, Tri-Port III, Helixed Tri-Port III, Spatula, Multi-Hole, Del Vecchio Track-12).
8. Substantial Equivalence Discussion
The following table compares the MicroAire PAL Single-Use Cannulas to the predicate device MicroAire PAL Multi-Use Cannulas and the reference device MicroAire PAD System Cannula with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
6
| Manufacturer | MicroAire Surgical Instruments | Comparison | |
|---|---|---|---|
| Trade Name | MicroAire PAL Single-Use | ||
| Cannula | MicroAire PAL Multi-Use | ||
| Cannula | |||
| 510k Number | K192694 | K171286 | N/A |
| Product Code | MUU | MUU | Same |
| Regulation | |||
| Number | 21 CFR 878.5040 | 21 CFR 878.5040 | Same |
| Regulation Name | Suction Lipoplasty System | Suction Lipoplasty System | Same |
| Indications for | |||
| Use | Indicated for the removal of | ||
| tissue or fluid from the body | |||
| during general surgical | |||
| procedures, including suction | |||
| Lipoplasty, for the purpose of | |||
| aesthetic body contouring | Indicated for the removal of | ||
| tissue or fluid from the body | |||
| during general surgical | |||
| procedures, including suction | |||
| Lipoplasty, for the purpose of | |||
| aesthetic body contouring | Same | ||
| Performance | |||
| Characteristics | • Designed to be used with | ||
| the PAL-730 Manual Wand | |||
| • Available in 2.4mm, 3mm, | |||
| 4mm and 5mm Diameters | |||
| • Available in 15cm, 22cm, | |||
| and 30cm Lengths | • Designed to be used with | ||
| the PAL-730 Manual Wand | |||
| • Available in 2.4mm, 3mm, | |||
| 4mm and 5mm Diameters | |||
| • Available in 15cm, 22cm, | |||
| 30cm and 40cm Lengths | Similar; multi-use | ||
| available in 40cm | |||
| length | |||
| Available | |||
| Fenestration | |||
| types | Single Port, Mercedes, Flared | ||
| Mercedes, Double Mercedes, | |||
| Tri-port II, Mirrored Tri-port, | |||
| Tri-port III, Spatula, Track-12, | |||
| Helixed Tri-Port, Spatula, | |||
| Multi-Hole, Bent Mercedes, | |||
| Bent Flared Mercedes | Mercedes, Flared Mercedes, | ||
| Double Mercedes, Tri-port II, | |||
| Mirrored Tri-port, Tri-port III, | |||
| Spatula, Track-12, Helixed Tri- | |||
| Port, Multi-Hole, Bent | |||
| Mercedes, Bent Flared | |||
| Mercedes | Similar; single-use | ||
| available in single | |||
| port and spatula | |||
| fenestration type | |||
| Function | Used for removal of tissue or | ||
| fluid from the body during | |||
| general surgical procedures | |||
| including suction Lipoplasty | |||
| for the purpose of aesthetic | |||
| body contouring | Used for removal of tissue or | ||
| fluid from the body during | |||
| general surgical procedures | |||
| including suction Lipoplasty | |||
| for the purpose of aesthetic | |||
| body contouring | Same | ||
| Mechanism of | |||
| action | The cannulas attach to the | ||
| PAL-730 Manual Wand and | |||
| suction tubing via a cannula | |||
| hub. This tubing connects to | |||
| an external suction source | |||
| (not part of the PAL System). | The cannulas attach to the | ||
| PAL-730 Manual Wand and | |||
| suction tubing via a cannula | |||
| hub. This tubing connects to | |||
| an external suction source | |||
| (not part of the PAL System). | Same |
| Table 5A - Comparison of Characteristics with Predicate Device | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | ---------------------------------------------------------------- | -- | -- | -- |
7
| Manufacturer | MicroAire Surgical Instruments | Comparison | |
|---|---|---|---|
| Trade Name | MicroAire PAL Single-Use | ||
| Cannula | MicroAire PAL Multi-Use | ||
| Cannula | |||
| Fluid and tissue are removed | |||
| from the body via the tubing | |||
| assisted by the external | |||
| suction source. The | |||
| handpiece is not powered | |||
| and does not reciprocate. | Fluid and tissue are removed | ||
| from the body via the tubing | |||
| assisted by the external | |||
| suction source. The | |||
| handpiece is not powered | |||
| and does not reciprocate. | |||
| Material | Cannula is a blunt tipped | ||
| hollow tube comprised of 304 | |||
| stainless steel. Cannula Hub | |||
| is comprised of a Release | |||
| Tab, made of Dupont Zytel | |||
| ST801 (nylon), a turbo plug | |||
| made of Silicon 70 Blue, USP | |||
| Class VI, and the hub itself | |||
| made of Polystyrene 825 | |||
| bonded together with | |||
| cyanoacrylate adhesive | Cannula is a blunt tipped | ||
| hollow tube comprised of 304 | |||
| stainless steel. Cannula Hub | |||
| is comprised of a Release | |||
| Tab, made of Dupont Zytel | |||
| ST801 (nylon), a Dowel Pin, | |||
| made of 410 or 416 or 18-8 | |||
| Stainless Steel, and the hub | |||
| itself made of Vectra MT1310 | |||
| bonded together with | |||
| cyanoacrylate adhesive | Similar; hub material | ||
| is polystyrene vs. | |||
| Vectra MT1310 | |||
| Sterile | Supplied Sterile; Gamma | ||
| Irradiation | Supplied non-sterile; Steam | ||
| Sterilized by end user | Different; single-use | ||
| is supplied gamma | |||
| sterilized | |||
| Single-Use | Yes | No | Different |
| Shelf Life | 1 year | N/A | Different |
| Complies with | |||
| ISO 10993-1 | Yes | Yes | Same |
Table 5B – Comparison of Characteristics with Reference Device
| Manufacturer | MicroAire Surgical Instruments | Comparison | |
|---|---|---|---|
| Trade Name | MicroAire PAL Single-Use | ||
| Cannula | MicroAire PAD System | ||
| Cannula | |||
| 510k Number | K192694 | K981922 | N/A |
| Product Code | MUU | MUU | Same |
| Regulation | |||
| Number | 21 CFR 878.5040 | 21 CFR 878.5040 | Same |
| Regulation Name | Suction Lipoplasty System | Suction Lipoplasty System | Same |
| Manufacturer | MicroAire Surgical Instruments | Comparison | |
| Trade Name | MicroAire PAL Single-Use | ||
| Cannula | MicroAire PAD System | ||
| Cannula | |||
| Indications for | |||
| Use | Indicated for the removal of | ||
| tissue or fluid from the body | |||
| during general surgical | |||
| procedures, including suction | |||
| lipoplasty, for the purpose of | |||
| aesthetic body contouring | For the removal of tissue or | ||
| fluid from the body during | |||
| general surgical procedures, | |||
| including suction lipoplasty, | |||
| for the purpose of aesthetic | |||
| body contouring | same | ||
| Function | Used for removal of tissue or | ||
| fluid from the body during | |||
| general surgical procedures | |||
| including suction lipoplasty | |||
| for the purpose of aesthetic | |||
| body contouring | Used for removal of tissue or | ||
| fluid from the body during | |||
| general surgical procedures | |||
| including suction lipoplasty | |||
| for the purpose of aesthetic | |||
| body contouring | Same | ||
| Material | Cannula is a blunt tipped | ||
| hollow tube comprised of 304 | |||
| stainless steel. Cannula Hub | |||
| is comprised of a Release | |||
| Tab, made of Dupont Zytel | |||
| ST801 (nylon), a turbo plug | |||
| made of Silicon 70 Blue, USP | |||
| Class VI, and the hub itself | |||
| made of Polystyrene 825 | |||
| bonded together with | |||
| cyanoacrylate adhesive | Cannula is a blunt tipped | ||
| hollow tube comprised of 304 | |||
| stainless steel with an | |||
| attached PVC suction tube | |||
| and optional syringe. The | |||
| cannula hub is comprised of a | |||
| Release Tab, made of Dupont | |||
| Zytel ST801 (nylon) and the | |||
| hub is made of Polystyrene |
- | same |
| Sterile | Supplied Sterile; Gamma
Irradiation | Supplied sterile; gamma
irradiation | same |
| Single-Use | Yes | Yes | Same |
| Shelf Life | 1 year | 4 years | Similar; testing is
ongoing to support a
4-year shelf life for
the Single-Use
Cannula, however,
was not available at
the time of
submission |
| Complies with
ISO 10993-1 | Yes | Yes | Same |
8
The PAL Single-Use Cannulas share the same indications for use, and same or similar device operation, overall technical and functional capabilities, and therefore are substantially equivalent to the predicate and reference devices. The PAL Single-Use Cannulas are similar in design and function to
9
the predicate and reference devices for the modes of operation and use. The PAL Single-Use Cannulas share the same indications for use, and same or similar device operation, overall technical and functional capabilities, and follow those of the reference device. The PAL Single-Use Cannula is sterilized by gamma irradiation, equal to the reference device.
9. Non-Clinical Performance Data
The following tests were performed to demonstrate that the proposed MicroAire PAL Single-Use Cannulas met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.
- . Sterilization validation per ISO 11137 - demonstrates SAL of 10°
- . Biocompatibility testing – Cytotoxicity, Sensitization, Irritation, per ISO 10993 - PASSED
In addition to the guidance and standards testing, the following testing was performed:
- . Mechanical Tensile Testing (fatigue, axial strength, pullout force, pushout force, bend) – Met specifications
- Air leakage and tubing connection force test - Met specifications
- Vacuum pressure testing - Met specification
- Transportation Testing per ASTM D4169 – demonstrates package integrity maintained
10. Statement of Substantial Equivalence – Conclusions Drawn
The MicroAire PAL® Single-Use Cannulas, as designed and manufactured, are determined to be substantially equivalent to the predicate and reference devices. Nonclinical testing demonstrates the subject device is substantially equivalent to the legally marked predicate and reference devices.