(121 days)
Not Found
No
The description focuses on mechanical and fluid dynamics (vacuum, vibration, irrigation) for tissue removal. There is no mention of AI/ML, image processing, or data analysis for decision-making or control.
Yes.
The device's intended use is for the "controlled aspiration of tissue and/or fluids during surgery of the Ventricular System," which involves removing unwanted material from the body, leading to a therapeutic benefit.
No
The Apollo™ System is described as a surgical instrument used for the controlled aspiration of tissue and/or fluids during surgery. Its primary function is to remove tissue and fluids, not to diagnose conditions.
No
The device description clearly outlines both reusable and disposable hardware components (vacuum generator, vibrational energy generator, saline irrigation, rigid cannula, vibrational wire). The performance studies also include extensive bench-top testing of these physical components.
Based on the provided information, the Apollo™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. This is a surgical procedure performed directly on a patient.
- Device Description: The device is described as a surgical instrument designed to aid in the removal of tissue and/or fluids during endoscopic-assisted microneurosurgery. It involves physical removal of material from the body.
- Lack of In Vitro Testing: IVD devices are used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The Apollo™ System's function is to remove material from the body during a surgical procedure.
- Performance Studies: The performance studies focus on biocompatibility and bench-top testing of the device's physical and mechanical properties, not on the analysis of biological samples for diagnostic purposes.
The Apollo™ System is a surgical device used for tissue and fluid removal during a medical procedure, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Apollo™ System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The Apollo™ disposable wand is inserted through the working channel of a neuroendoscopic trocar.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
The Apollo System is a two component surgical instrument designed to aid a physician in the removal of tissue and/or fluids during endoscopic-assisted microneurosurgery. The reusable component has three functions. These functions are 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 pass through the working channel of various neuro-endoscope trocars allowing visualization of the procedure. The method of action of removal is first vacuum aspiration, which draws the tissue and/or fluid into the lumen of the wand. Next, a vibrational wire is agitated inside the lumen of the wand facilitating movement of any tissue and/or fluid that may otherwise clog the lumen. Saline irrigation has the purpose of providing additional fluid to transport the tissue through the cannula. The irrigation and inner vibration wire components of the disposable wand provide an improvement over existing methods of suction aspiration through a cannula in that the use of the Apollo wand can prevent clogging. Intended users for this device are physicians who have received appropriate training in endoscopicassisted microneurosurgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ventricular System
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in endoscopic-assisted microneurosurgery.
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)
Summary of Non-clinical Data:
Included in this section are descriptions of the testing's, which substantiates the safe and effective performance of the Apollo™ System as well as its substantial equivalence to the predicate devices:
- Biocompatibility .
- Design Verification (Bench-Top Testing) .
The subject Apollo™ System components met all established requirements.
Biocompatibility Testing:
Biocompatibility tests conducted with Penumbra Apollo™ System were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for a blood contacting permanent implant device. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
| Test | Results | Conclusions |
|---|---|---|
| In vitro Cytotoxicity (MEM Elution) | Sample extracts exhibited Grade 2 (mild reactivity) | Non-cytotoxic |
| Sensitization (Magnusson - Kligman Method) | Samples exhibited Grade: 0 (No sensitization response) | Does not elicit sensitization response |
| Irritation (Intracutaneous Reactivity) | Sample exhibited Grade 0.0 (saline extract) and Grade 0.1 (sesame oil extract) | Non-irritant |
| Systemic Toxicity - Systemic Injection (ISO) | No evidence of systemic toxicity from sample extracts | Does not cause systemic toxicity |
| Material Mediated Pyrogen | No animals had a temperature rise ≥ 0.5°C | Non-pyrogenic |
| Subchronic Toxicity (Subacute Toxicity) | Negative for signs of systemic toxicity | Does not cause systemic toxicity |
| Hemocompatibility - Thrombosis (Dog Thrombogenicity) | Device exhibited acceptable reaction to blood | Non-thrombogenic |
| Coagulation (PTT) | Test article clotting times similar to the predicate device | Acceptable coagulation response |
| Hematology (Hemolysis - Direct Contact) | Hemolytic index = 1.04% Corrected hemolytic index = 0.23% | Non-hemolytic |
| Hematology (Hemolysis - Indirect (Extract) Contact) | Hemolytic index = 0.53% Corrected hemolytic index = 0.00% | Non-hemolytic |
| Genotoxicity - Ames Mutagenicity | Tests show no zone of increased reversion or of toxicity | Non-mutagenic |
| Mouse Lymphoma | Non-genotoxic and non-clastogenic) | Non-mutagenic |
| In vivo Mouse micronucleus | No manifestation of toxicity nor biologically significant erythrpoietic disturbances resulting in delayed mutagenesis. No biologically significant increases in mPCE production. | Non-mutagenic |
In summary, non-clinical testing found the Penumbra Apollo™ System to be biocompatible according to the requirements of ISO 10993. Additionally, the product was found to be non-pyrogenic. The physical, mechanical and performance testing of the Penumbra Apollo™ System demonstrate that the product is substantially equivalent to the currently marketed predicate devices.
Bench-top Testing:
The physical, mechanical and performance testing of the Apollo™ System components demonstrates that the devices are substantially equivalent to the currently marketed predicate devices:
Design Verification testing was conducted to evaluate the physical and mechanical properties of the Apollo™ System components. All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements. The tests performed on the Apollo™ System components included:
| Test | Methods | Conclusions |
|---|---|---|
| Disposable Component Testing - Tensile Test | The following device connections and bonds were tested for tensile strength: - Sonic Connector to Wire - RHV to Irrigation Catheter Shaft - Proximal Aspiration Tubing to Y-Connector - Wand-Canister Tubing to Male Swivel Connector - Wand-Canister Tubing | Component bonds and connections meet or exceed minimal tensile specifications |
| Corrosion | to Suction Connector - Aspiration Tubing to T-Connector Device was subjected to testing to evaluate | Device meets criteria as non-corrosive |
| Simulated Use | potential for corrosion Device tested for simulated use outputs | Device meets or exceeds simulated use testing specifications |
| Fatigue | Device tested for fatigue based outputs | Device meets or exceeds fatigue testing specifications |
| Reusable Capital Equipment - IEC 60601-1 | Tested Apollo System for compliance with standard | Complies with standard |
| IEC 60601-1-2 | Tested Apollo System for compliance with standard | Complies with standard |
| The Apollo System controls shall be easily identifiable by the User. | Tested Apollo System for usability | Controls are easily identifiable |
| The Apollo System controls shall be validated for Usability | Tested Apollo System for usability | Validated for Usability |
| The Apollo System reusable component should supply uniform irrigation and vibrational energy for an entire case | Tested Apollo System for functionality | Meets or exceeds specifications to supply uniform irrigation and vibrational energy for an entire case |
| The Apollo System will be a durable piece of capital equipment | Tested Apollo System for durability | The Apollo System is a durable piece of capital equipment |
| The Apollo System should be quiet | Tested Apollo System for audible noise level | The Apollo System meets the audible noise specification |
| The Canister should have volume reference markings | Verified that Canister has volume reference markings | The Canister adequately exhibits the design feature |
| Canister should be able to withstand maximum pressure delivered by the Apollo System | Tested the Canister at maximum pressure | Canister meets specifications at maximum pressure |
| Canister lid should include a feature to prevent excess fluid from entering the Apollo System. | Verified that the Canister contains a feature to prevent excess fluids from entering the Apollo System | The Canister adequately exhibits the design feature |
All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the Apollo™ System components are acceptable for the intended use and substantially equivalent 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.
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
K132 931
JAN 1 7 2014
510(k) SUMMARY l
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra Inc. is providing the summary of Substantial Equivalence for the Penumbra Apollo™ System.
Sponsor/Applicant Name and Address 1.1
Penumbra Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
Sponsor Contact Information 1.2
Seth A. Schulman Director, Regulatory Affairs Phone: 510-748-3223 FAX: 510-217-6414 email: seth.schulman@Penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
December 13, 2013
1.4 Device Trade or Proprietary Name
Apollo™ System
Device Common/Usual or Classification Name 1.5
Endoscope, neurological (Product Code: GWG, 21 CFR §882.1480)
Identification of the Legally Marketed Devices to which Equivalence is Being 1.6 Claimed:
| Name of Predicate Device | Name of Manufacturer (Town,
State) | 510(k) Number |
|-----------------------------|---------------------------------------|---------------|
| Aesculap Aspiration Cannula | Aesculap, Inc.
Center Valley, PA | K983365 |
| Penumbra Pump MAX™ | Penumbra, Inc.
Alameda, CA | K122756 |
1
1.7 Device Description:
The Apollo System is a two component surgical instrument designed to aid a physician in the removal of tissue and/or fluids during endoscopic-assisted microneurosurgery. The reusable component has three functions. These functions are 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 pass through the working channel of various neuro-endoscope trocars allowing visualization of the procedure. The method of action of removal is first vacuum aspiration, which draws the tissue and/or fluid into the lumen of the wand. Next, a vibrational wire is agitated inside the lumen of the wand facilitating movement of any tissue and/or fluid that may otherwise clog the lumen. Saline irrigation has the purpose of providing additional fluid to transport the tissue through the cannula. The irrigation and inner vibration wire components of the disposable wand provide an improvement over existing methods of suction aspiration through a cannula in that the use of the Apollo wand can prevent clogging. Intended users for this device are physicians who have received appropriate training in endoscopicassisted microneurosurgery.
1.8 Indications for Use:
The Apollo™ System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The Apollo™ disposable wand is inserted through the working channel of a neuroendoscopic trocar.
| | Aesculap Aspiration
Cannula | Penumbra Apollo™
System |
|-------------------|---------------------------------|------------------------------------------------------------------------------------|
| 510(k) No. | K983365 | K132931 |
| Classification | Class II, GWG | Class II, GWG |
| Materials | | |
| Wand | Polymer, Metal | Same |
| Tubing | N/A (Not supplied with
Wand) | Polymer |
| Canister | N/A | Polymer |
| Capital Equipment | N/A | General electro-medical
equipment compliant
with IEC 60601-1
requirements |
| Sterilization | EtO | Same |
| Shelf-Life | 36-Months | Same |
Predicate Comparison 1.9
2
| | Aesculap Aspiration
Cannula | Penumbra Apollo™
System |
|----------------------------|----------------------------------|-------------------------------------|
| Vacuum Source | Hospital based suction
system | System based aspiration
pump |
| Vibration Energy
Source | N/A | System based vibration
generator |
| | Penumbra Pump
MAXTM | Penumbra ApolloTM
System Pump |
|-------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K051758 | K132931 |
| Classification | Class II, JCX | Class II, GWG |
| Indication | The Penumbra
Aspiration Pump is
intended for general
suction use in hospitals
or clinics. | The ApolloTM System is
used for the controlled
aspiration of tissue
and/or fluids during
surgery of the
Ventricular System.
The ApolloTM
disposable wand is
inserted through the
working channel of a
neuroendoscopic trocar. |
| Specifications | | |
| IEC 60601-1
Compliance | Yes | SAME |
| IEC 60601-1-2
Compliance | Yes | SAME |
| Voltage | 100-115Vac / 230 Vac | SAME |
| Frequency | 50 Hz / 60 Hz | SAME |
| Vacuum Range | 0-29 inHg (0-98.2 kPa) | SAME |
| Flow Rate | 0-23 LPM
0-0.8 SCFM | SAME |
| Fuses | Two 5 amp slow blow
fuse (250 Vac) | SAME |
| Motor and Pump
Description | Oil-less, rotating pump | SAME |
| Sterilization | Non-Sterile | SAME |
| Shelf-Life | N/A | SAME |
1.10 Summary of Non-clinical Data:
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding safety and effectiveness of the device follows.
Included in this section are descriptions of the testing's, which substantiates the safe and effective performance of the Apollo™ System as well as its substantial equivalence to the predicate devices:
3
- Biocompatibility .
- Design Verification (Bench-Top Testing) .
The subject Apollo™ System components met all established requirements.
1.10.1 Biocompatibility Testing
Biocompatibility tests conducted with Penumbra Apollo™ System were selected in accordance with ISO-10993 -1 guidelines (Biological Evaluation of Medical Devices) for a blood contacting permanent implant device. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
| Test | Results | Conclusions |
|---|---|---|
| In vitro Cytotoxicity (MEM Elution) | Sample extracts exhibited | |
| Grade 2 (mild reactivity) | Non-cytotoxic | |
| Sensitization (Magnusson - Kligman Method) | Samples exhibited Grade: 0 | |
| (No sensitization response) | Does not elicit | |
| sensitization | ||
| response | ||
| Irritation (Intracutaneous Reactivity) | Sample exhibited Grade 0.0 | |
| (saline extract) and Grade 0.1 | ||
| (sesame oil extract) | Non-irritant | |
| Systemic Toxicity | ||
| Systemic Injection (ISO) | No evidence of systemic | |
| toxicity from sample extracts | Does not cause | |
| systemic toxicity | ||
| Material Mediated Pyrogen | No animals had a temperature | |
| rise ≥ 0.5°C | Non-pyrogenic | |
| Subchronic Toxicity (Subacute Toxicity) | Negative for signs of systemic | |
| toxicity | Does not cause | |
| systemic toxicity | ||
| Hemocompatibility | ||
| Thrombosis (Dog Thrombogenicity) | Device exhibited acceptable | |
| reaction to blood | Non- | |
| thrombogenic | ||
| Coagulation (PTT) | Test article clotting times | |
| similar to the predicate device | Acceptable | |
| coagulation | ||
| response | ||
| Hematology (Hemolysis - Direct Contact) | Hemolytic index = 1.04% | |
| Corrected hemolytic index = | ||
| 0.23% | Non-hemolytic | |
| Hematology (Hemolysis - Indirect (Extract) | ||
| Contact) | Hemolytic index = 0.53% | |
| Corrected hemolytic index = | ||
| 0.00% | Non-hemolytic | |
| Genotoxicity | ||
| Ames Mutagenicity | Tests show no zone of | |
| increased reversion or of | ||
| toxicity | Non-mutagenic | |
| Mouse Lymphoma | Non-genotoxic and non- | |
| clastogenic) | Non-mutagenic |
4
| Test | Results | Conclusions |
|---|---|---|
| In vivo Mouse micronucleus | No manifestation of toxicity | |
| nor biologically significant | ||
| erythrpoietic disturbances | ||
| resulting in delayed | ||
| mutagenesis. No biologically | ||
| significant increases in mPCE | ||
| production. | Non-mutagenic |
In summary, non-clinical testing found the Penumbra Apollo™ System to be biocompatible according to the requirements of ISO 10993. Additionally, the product was found to be non-pyrogenic. The physical, mechanical and performance testing of the Penumbra Apollo™ System demonstrate that the product is substantially equivalent to the currently marketed predicate devices.
1.10.2 Bench-top Testing
The physical, mechanical and performance testing of the Apollo™ System components demonstrates that the devices are substantially equivalent to the currently marketed predicate devices:
Design Verification testing was conducted to evaluate the physical and mechanical properties of the Apollo™ System components. All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements. The tests performed on the Apollo™ System components included:
5
| Test | Methods | Conclusions |
|---|---|---|
| Disposable Component Testing | ||
| Tensile Test | The following device | |
| connections and bonds | ||
| were tested for tensile | ||
| strength: |
- Sonic Connector to
Wire - RHV to Irrigation
Catheter Shaft - Proximal Aspiration
Tubing to Y-Connector - Wand-Canister Tubing
to Male Swivel
Connector - Wand-Canister Tubing | Component
bonds and
connections meet
or exceed
minimal tensile
specifications |
| Corrosion | to Suction Connector - Aspiration Tubing to
T-Connector
Device was subjected to
testing to evaluate | Device meets
criteria as non- |
| Simulated Use | potential for corrosion
Device tested for
simulated use outputs | corrosive
Device meets or
exceeds
simulated use
testing
specifications |
| Fatigue | Device tested for fatigue
based outputs | Device meets or
exceeds fatigue
testing
specifications |
| Reusable Capital Equipment | | |
| IEC 60601-1 | Tested Apollo System
for compliance with
standard | Complies with
standard |
| IEC 60601-1-2 | Tested Apollo System
for compliance with
standard | Complies with
standard |
| The Apollo System controls shall be easily
identifiable by the User. | Tested Apollo System
for usability | Controls are
casily identifiable |
| The Apollo System controls shall be validated for
Usability | Tested Apollo System
for usability | Validated for
Usability |
| The Apollo System reusable component should
supply uniform irrigation and vibrational energy for
an entire case | Tested Apollo System
for functionality | Meets or exceeds
specifications to
supply uniform
irrigation and
vibrational
energy for an
entire case |
| The Apollo System will be a durable piece of capital
equipment | Tested Apollo System
for durability | The Apollo
System is a |
| Test | Methods | Conclusions |
| The Apollo System should be quiet | Tested Apollo System
for audible noise level | The Apollo
System meets the
audible noise
specification |
| The Canister should have volume reference
markings | Verified that Canister
has volume reference
markings | The Canister
adequately
exhibits the
design feature |
| Canister should be able to withstand maximum
pressure delivered by the Apollo System | Tested the Canister at
maximum pressure | Canister meets
specifications at
maximum
pressure |
| Canister lid should include a feature to prevent
excess fluid from entering the Apollo System. | Verified that the
Canister contains a
feature to prevent
excess fluids from
entering the Apollo
System | The Canister
adequately
exhibits the
design feature |
6
All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the Apollo™ System components are acceptable for the intended use and substantially equivalent to the predicate devices.
1.10.3 Sterilization
The Penumbra Apollo™ System contains several components. The following table identifies which components are sterile or non-sterile. None of the Penumbra Apollo™ System components can be end-user sterilized.
| Component | Sterility |
|---|---|
| Wand | Sterile |
| Tubing | Sterile |
| Canister | Non-Sterile |
| Generator | Non-Sterile |
| Pump | Non-Sterile |
| I.V. Pole | Non-Sterile |
| Footswitch | Non-Sterile |
| Table 1: Component Sterility | = | ||||
|---|---|---|---|---|---|
| ------------------------------ | -- | -- | -- | -- | --- |
The Penumbra Apollo™ System disposable wands and tubing are packaged and submitted to a contract ISO certified facility for the sterilization of medical devices.
7
The EtO validation and routine sterilization process of the Penumbra Apollo™ System disposable wands and tubing is based on EN ISO 11135' ensuring a Sterility Assurance Level (SAL) of 10-6.
1.10.4 Shelf-Life
The expiration period for the Penumbra Apollo™ System disposable wands and tubing are currently established for 12-months based on 1 yr. accelerated aging test results. The shelf life protocol specifies a test regimen using both accelerated and confirmatory realtime testing methodologies to enable Penumbra to extend the shelf life as additional data becomes available. Upon successful completion of the protocol, Penumbra will maintain a 36-month shelf life for the product.
Penumbra Apollo™ System disposable wands and tubing used in the shelf life studies were produced according to approved production procedures. Acceptance criteria were based on the sterile finished goods testing requirements. All devices used in the shelf-life studies completed 2x sterilization processes prior to test initiation. Packaging materials (both primary and secondary) were tested to validate their properties over the intended shelf life.
1.10.5 Summary of Substantial Equivalence
The Apollo™ System components are substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
EN ISO 11135: 2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
8
Image /page/8/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
Penumbra, Inc. % Mr. Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502
Re: K132931
Trade/Device Name: Penumbra Apollo™ System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: December 13, 2013 Received: December 18, 2013
Dear Mr. Schulman:
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
9
Page 2 - Mr. Seth A. Schulman
,……
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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 vours.
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. . Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K132931
Device Name: Penumbra Apollo™ System
Indications For Use:
The Apollo™ System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The Apollo™ disposable wand is inserted through the working channel of a neuroendoscopic trocar.
V Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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