(178 days)
Not Found
No
The description focuses on mechanical functions (vacuum, vibration, irrigation) and image guidance, with no mention of AI or ML in the device description, intended use, or specific sections for AI/ML mentions.
Yes
The device is used to remove tissue and/or fluid during surgery, which is a therapeutic intervention aimed at treating a condition or disease.
No
The device is described as an aspiration system for removing tissue and/or fluid during surgery. Its primary function is therapeutic (removal of material), not diagnostic (identifying a condition or disease). While it's used with image-guidance, the device itself doesn't perform diagnostic imaging or analysis.
No
The device description clearly outlines multiple hardware components including a generator, vacuum pump, collection canister, foot switch, and a disposable wand. It is not solely software.
Based on the provided information, the Apollo System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details components for vacuum generation, vibrational energy, saline irrigation, and aspiration of tissue and fluid from the patient. The collected material is for disposal, not for diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Apollo System's function is to remove tissue and fluid from the body during surgery, not to analyze it for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
The Apollo System is designed to aid a physician in the removal of tissue and/or fluids during image-guided neurosurgery. The reusable components have three functions; vacuum generation, generation of vibrational energy, and saline irrigation. The disposable component, the Wand is a rigid cannula to remove tissue and/or fluid with the assistance of vibrational energy and aspiration. The disposable wand is designed to be image-guided, such as passing through the working channel of various neuro-endoscope trocars, allowing visualization of the procedure. To aid in tissue and/or fluid removal, the Apollo Generator provides the saline irrigation and vibrational energy to the Wand to ensure the Wand does not become clogged. Aspiration of the tissue and/or fluid is performed by the Apollo Vacuum Pump. Any tissue and/or fluid removed is collected in the Apollo Collection Canister. Activation of saline infusion and vibrational energy is controlled by the Apollo Foot Switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ventricular System or Cerebrum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / neurosurgery
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)
A literature review was conducted to substantiate the safe and effective performance of the Apollo System, as well as its substantial equivalence to the predicate devices. Current literature was reviewed in relationship to device indications. Review concluded the revised indication for use is appropriate. Additionally, revised labeling was found to have a safety and effectiveness profile that is similar to the predicate devices.
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.
Apollo™ System, K132931, SONOTOME™ System, K990572
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.
Not Found
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
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
March 24, 2016
Penumbra. Inc. Ms. Mary Rose Senior Manager, Regulatory Affairs One Penumbra Place Alameda, California 94502
Re: K152699
Trade/Device Name: Apollo™ System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: February 12, 2016 Received: February 16, 2016
Dear Ms. Rose:
This letter corrects our substantially equivalent letter of March 17, 2016.
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 Actinclude requirements for annual registration. Ilisting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152699
Device Name Apollo™ System
Indications for Use (Describe)
The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
(as required by 21 CFR 807.92)
1.1 Submitter
Penumbra Inc. One Penumbra Place Alameda, CA 94502, USA
Contact Person: Mary Rose, Senior Manager, Regulatory Affairs Phone: 510-748-3346 FAX: 510-217-6414 email: mrose@Penumbrainc.com
Device Trade or Proprietary Name 1.2
Apollo™ System
Device Common/Usual or Classification Name 1.3
Endoscope, neurological (Product Code: GWG)
Primary Device Classification 1.4
II Regulatory Class: Classification Panel: Neurology Classification Name: Endoscope, neurological Regulation Number: 21 CFR 882.1480 Product Code: GWG
1.5 Predicate Devices
Apollo™ System, K132931 SONOTOME™ System, K990572
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| Table 1: Predicate Device Comparison | |||
|---|---|---|---|
| SONOTOME TM | |||
| System | Apollo™ System | Subject Device: | |
| Apollo™ System | |||
| 510(k) No. | K990572 | K132931 | K152699 |
| Classification | Class II, LFL | Class II, GWG | Class II, GWG |
| Indications for | |||
| Use | Breakup and removal | ||
| of soft tissues in | |||
| Neurosurgery, GI and | |||
| affiliated organ | |||
| surgery, Urology, | |||
| General surgery, | |||
| Plastic and | |||
| reconstructive surgery, | |||
| Orthopedic, GYN, | |||
| Thoracic. | The Apollo System is | ||
| used for the controlled | |||
| aspiration of tissue | |||
| and/or fluid during | |||
| surgery of the | |||
| Ventricular System. | |||
| The Apollo Wand is | |||
| inserted through the | |||
| working channel of a | |||
| neuro-endoscopic | |||
| trocar. | The Apollo System is | ||
| used for the controlled | |||
| aspiration of tissue | |||
| and/or fluid during | |||
| surgery of the | |||
| Ventricular System or | |||
| Cerebrum. | |||
| Basic Operating | |||
| Principle | Metal tip driven by | ||
| ultrasound causing | |||
| tissue fragmentation | |||
| and aspiration through | |||
| tip. | AC power is converted | ||
| from the generator into | |||
| vibrational energy and | |||
| saline irrigation to the | |||
| distal tip of the Wand, | |||
| which removes tissue | |||
| and/or fluids through an | |||
| aspiration lumen. | Same as K132931 | ||
| cleared device. | |||
| System Console | Self-contained with | ||
| ultrasonic, irrigation, | |||
| and aspiration | |||
| subsystems. | Self-contained with | ||
| irrigation and aspiration | |||
| subsystems. | |||
| Powered by a generator | |||
| and vacuum. | Same as K132931 | ||
| cleared device. | |||
| Amplitude of | |||
| Vibration of tip | 240 microns, peak to | ||
| peak | 25 microns, peak to | ||
| peak | Same as K132931 | ||
| cleared device. | |||
| Vibration | |||
| Frequency | 20 kHz | 21 kHz | Same as K132931 |
| cleared device. | |||
| Irrigation Flow | |||
| Rate | 10-400 ml/min | 30 ml/min | Same as K132931 |
| cleared device. | |||
| Aspiration | 5-15 in. Hg | 0-29 in. Hg | Same as K132931 |
| cleared device. | |||
| Disposable | ● Surgical Tips | ● Wand | |
| Table 1: Predicate Device Comparison | |||
| SONOTOME ™ System | Apollo™ System | Subject Device: | |
| Apollo™ System | |||
| components | • Suction trap, | ||
| • Irrigation/suction tubing set | • Collection Canister, filter and pump-canister tubing | ||
| • Irrigation Tubing | |||
| Power requirements | 105-130 v a-c, 60Hz, 500 watts | 100-115V (60Hz), 100V (50Hz) | Same as K132931 cleared device. |
1.6 Predicate Comparison
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1.7 Device Description:
The Apollo System is designed to aid a physician in the removal of tissue and/or fluids during image-guided neurosurgery. The reusable components have three functions; vacuum generation, generation of vibrational energy, and saline irrigation. The disposable component, the Wand is a rigid cannula to remove tissue and/or fluid with the assistance of vibrational energy and aspiration. The disposable wand is designed to be image-guided, such as passing through the working channel of various neuro-endoscope trocars, allowing visualization of the procedure. To aid in tissue and/or fluid removal, the Apollo Generator provides the saline irrigation and vibrational energy to the Wand to ensure the Wand does not become clogged. Aspiration of the tissue and/or fluid is performed by the Apollo Vacuum Pump. Any tissue and/or fluid removed is collected in the Apollo Collection Canister. Activation of saline infusion and vibrational energy is controlled by the Apollo Foot Switch.
Indications for Use: 1.8
The Apollo System is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum.
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1.9 Summary of Non-clinical Data
A literature review was conducted to substantiate the safe and effective performance of the Apollo System, as well as its substantial equivalence to the predicate devices. Current literature was reviewed in relationship to device indications. Review concluded the revised indication for use is appropriate. Additionally, revised labeling was found to have a safety and effectiveness profile that is similar to the predicate devices.
1.10 Summary of Substantial Equivalence
The Apollo System was found to have a safety and effectiveness profile that is similar to the predicate devices.